{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 89781 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "1818910-2020-11325", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20190407", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "HEALTH PROFESSIONAL", "L" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "UK", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "464078", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "UNKNOWN HIP ACETABULAR CUP", "generic_name": "HIP ACETABULAR CUP", "manufacturer_d_name": "DEPUY ORTHOPAEDICS INC US", "manufacturer_d_address_1": "700 ORTHOPAEDIC DRIVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "WARSAW", "manufacturer_d_state": "IN", "manufacturer_d_zip_code": "46581", "manufacturer_d_zip_code_ext": "0988", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "465810988", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK HIP ACETABULAR CUP", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "LPH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "1818910" ], "fei_number": [ "1818910" ], "device_name": "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3358", "device_class": "2" } } ], "product_problems": [ "Loss of Osseointegration", "Loss of Osseointegration" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/05/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250812", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Inadequate Osseointegration", "No Code Available", "Inadequate Osseointegration", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200420", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000707", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200420", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "317933377", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. THE COMPLAINT INFORMATION PROVIDED HAS BEEN REVIEWED FOR COMPLAINT CODING, MEDICAL DEVICE REPORTING, AND OTHER DATA REQUIRED BY THE COMPLAINT SYSTEM. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION, IF APPLICABLE, WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A. WITHOUT THE PHYSICAL COMPLAINT SAMPLE(S) ASSOCIATED WITH THIS REPORT, IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICE(S) FAILED TO MEET SPECIFICATION(S) AT THE TIME IT WAS RELEASED FOR DISTRIBUTION. THE DEVICE(S) ASSOCIATED WITH THIS EVENT WERE USED IN THE TREATMENT OF THE PATIENT AS PRESCRIBED BY THE PRESIDING SURGEON. FROM THE EVENT INFORMATION RECEIVED, IT WAS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATES THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. POST MARKET SURVEILLANCE IS PER SEP 419." }, { "mdr_text_key": "190059561", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4)." }, { "mdr_text_key": "190059562", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE LITERATURE ARTICLE ENTITLED, \"EARLY RESULTS OF A HIGH FRICTION SURFACE COATED UNCEMENTED SOCKET IN REVISION HIP ARTHROPLASTY\" WRITTEN BY VINAY CHACKO, PRANSHU AGRAWAL, MARTYN L. PORTER AND TIM N. BOARD PUBLISHED BY HIP INTERNATIONAL ACCEPTED BY PUBLISHER 07 APRIL 2019 WAS REVIEWED. THE ARTICLE'S PURPOSE IS TO ASSESS THE EARLY RESULTS OF THE PINNACLE SOCKET IN A REVISION SETTING. ALL PATIENTS RECEIVED REVISION SURGERIES OF UNIDENTIFIED ORIGINAL IMPLANTS BEING REPLACED WITH PINNACLE GRIPTION CUP. REVISION SURGERIES WERE PERFORMED BETWEEN AUGUST 2009 AND DECEMBER 2016 WITH A DATA SET OF 67 MEN AND 79 WOMEN WITH AGE RANGE OF 19-88 YEARS. THE ARTICLE REPORTS FIXATION SCREWS WERE UTILIZED IN SOME CASES; VARYING LINERS WERE UTILIZED: NEUTRAL, LIPPED AND LATERALIZING LINERS; VARYING BEARING SURFACE MATERIALS WERE UTILIZED: METAL ON POLY OR CERAMIC ON POLY. ARTICLE REPORTS SOME FEMORAL REVISIONS WERE PERFORMED BUT DID NOT DISCUSS OR IDENTIFY ANY ASPECTS OF FEMORAL STEMS. THEREFORE, ONLY THE CUP, LINER, ONE SCREW AND HEAD WILL BE CAPTURED IN THIS COMPLAINT. THE ARTICLE DOES NOT PROVIDE ANY CLARITY ON SPECIFIC COMPONENTS ASSOCIATED WITH THE ADVERSE EVENTS. FIGURE 3 PROVIDES RADIOGRAPHIC IMAGING OF CASE 1 OF \"LOOSE GRIPTION SOCKET AND AUGMENT\" AND CROSS REFERENCING WITH NARRATIVE DESCRIPTION PROVIDES CLARITY THAT ONLY CASE HAD AN AUGMENT IN THE DATA SET. FIGURE 4 PROVIDES RADIOGRAPHIC IMAGING OF \"FAILED SOCKET FIXATION WITH MEDIAL MIGRATION.\" FIGURE 5 PROVIDES RADIOGRAPHIC IMAGING OF \"SUCCESSFUL LEFT HIP REPLACEMENT WITH GRIPTION SOCKET.\" DEPUY PRODUCTS: PINNACLE GRIPTION CUP, PINNACLE GRIPTION AUGMENT (ONE CASE), SCREW (QUANTITIES UNSPECIFIED), LINER (POLY MATERIAL AND VARIOUS MODELS), HEAD (METAL OR CERAMIC). ADVERSE EVENTS: DEEP INFECTION (TREATED BY RE-REVISION). RECURRENT DISLOCATION (TREATED BY RE-REVISION OR CLOSED REDUCTION). ASEPTIC CUP LOOSENING WITH RADIOGRAPHIC DETECTION OF MIGRATION (TREATED BY RE-REVISION). TROCHANTERIC PAIN SYNDROME (NO INTERVENTIONS REPORTED AND FEMORAL COMPONENT UNKNOWN/NOT IDENTIFIED/NOT REPORTED). SUPERFICIAL INFECTION (NO INTERVENTIONS REPORTED). THIGH PAIN (NO INTERVENTIONS REPORTED AND FEMORAL COMPONENT UNKNOWN/NOT IDENTIFIED/NOT REPORTED). CASE 1 - RADIOGRAPHIC IMAGE OF LOOSE CUP AND LOOSE AUGMENT (TREATED BY RE-REVISION AS INFORMATION IS PROVIDED IN NARRATIVE DESCRIPTION)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/07/2020" } ] }