MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: source: (b)(6).Concomitant medical products: unknown liner, catalog number :00786400900 lot number:63456639 brand: femoral stem; catalog number : 01.00561.314 lot number:2936141 brand: wagn cone prosthesis.Multiple reports were submitted along with this report: 0001822565-2021-03311.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in patient.
Event or Problem Description
It was reported that the patient was revised due to pain and dislocation approximately 17 days post implantation.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: catalog number: 00631004022 lot number: 63254391 brand: xlpe liners; catalog number :00786400900 lot number:63456639 brand: femoral stem; catalog number : 01.00561.314 lot number:2936141 brand: wagn cone prosthesis; catalog number: 00801802230 lot number: 63452825 brand: cocr heads.Multiple reports were submitted along with this report 0002648920-2021-00406; 0001822565-2021-03311; 0001822565-2021-03565.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: a left tha was performed due to oa and hip dysplasia.A revision occurred as a dislocation occurred.The acetabulum was found well fixed.The head and stem were explanted.Reported event was confirmed by review of medical records provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Per the follow up information, the root cause of the reported issue is attributed to the patient failing to follow medical advice and participating in activities that caused their hip to dislocate and the stem to loosen.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.
Event or Problem Description
It was reported that the patient was revised due to pain and dislocation approximately 17 days post implantation.During the revision, the femoral stem was found loose.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: FEMORAL HEAD STERILE PRODUCT
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12868662
• Report Number: 0002648920-2021-00406
• Device Sequence Number: 6025511
• Product Code: LPH
• UDI-Device Identifier: 00889024144552
• UDI-Public: (01)00889024144552(17)260831(10)63452825
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00801802230
• Device Lot Number: 63452825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 36 KG