{ "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": "2026-07-07", "results": { "skip": 0, "limit": 1, "total": 855618 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "N", "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": "Malfunction", "report_number": "0001825034-2020-01725", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K101086", "date_of_event": "20200407", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "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": "466552", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "TPRLC 133 T1 PPS HO 15X150MM 0MM T1", "generic_name": "PROSTHESIS, HIP", "manufacturer_d_name": "ZIMMER BIOMET, INC.", "manufacturer_d_address_1": "56 E. BELL DRIVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "WARSAW", "manufacturer_d_state": "IN", "manufacturer_d_zip_code": "46582", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "46582", "device_operator": "HEALTH PROFESSIONAL", "model_number": "N/A", "catalog_number": "51-104150", "lot_number": "6127291", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200519", "device_report_product_code": "KWA", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3330", "device_class": "3" } } ], "product_problems": [ "Device Contaminated During Manufacture or Shipping", "Device Contaminated During Manufacture or Shipping" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/25/2020", "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": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Patient Involvement", "No Patient Involvement" ] } ], "distributor_city": "", "date_report": "20200630", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000092", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200407", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "315966674", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: UDI#: (B)(4). THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, D4, G4, G7, H2, H3, H4, H6, H10. EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE STERILE PACKAGING (BLISTER AND FOAM) IS DAMAGED AND THERE IS DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING INSIDE THE STERILE BARRIER. THEREFORE, THE REPORTED EVENT IS CONFIRMED. STERILITY WAS NOT COMPROMISED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IT LIKELY TO BE DAMAGE DURING TRANSIT CAUSING THE FOAM PACKAGING TO BECOME ABRADED AND SHED. THE DEVICE EVALUATION FOUND NO MALFUNCTION AND THE EVENT DID NOT CONTRIBUTE TO INJURY, EVENT IS NO LONGER CONSIDERED REPORTABLE, AND INITIAL REPORT SHOULD BE VOIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS." }, { "mdr_text_key": "315966675", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "UPON INVESTIGATION, IT HAS BEEN DETERMINED THAT THE DEBRIS IN THE STERILE PACKAGING DID NOT COMPROMISE STERILITY. EVENT IS NO LONGER CONSIDERED REPORTABLE, AND INITIAL REPORT SHOULD BE VOIDED." }, { "mdr_text_key": "200880692", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01724, 0001825034-2020-01723." }, { "mdr_text_key": "200880833", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT HAS BEEN REPORTED CIRCULATED ITEMS WERE INVESTIGATED AND IDENTIFIED DEBRIS IN STERILE PACKAGE. NO PATIENTS WERE INVOLVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME." } ], "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": "06/30/2020" } ] }