MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: ref 8757-050-01, lot 63719333, tm shell; ref 8752-009-32, lot 63406302 ,longevity liner (both listed implanted, no further records to correlate); ref 8751-009-32, lot 63637927, longevity liner (both listed implanted, no further records to correlate); ref 6250-065-30, lot 63838846, screw; ref 7713-006-00, lot 63812201, stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2021 -02877.
Event or Problem Description
It was reported by patients¿ legal counsel that the patient underwent a left hip arthroplasty.Subsequently, patient has filed an unknown allegation on the hip approximately 4 years later.No revision has been reported to date.No further event information available at the time of this report.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• 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
• MDR Report Key: 12578283
• Report Number: 0002648920-2021-00318
• Device Sequence Number: 13728423
• Product Code: LPH
• UDI-Device Identifier: 00889024144675
• UDI-Public: (01)00889024144675(17)271031(10)63782463
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00801803202
• Device Lot Number: 63782463
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other