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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) g2: foreign: australia.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision procedure 4 and a half years post implantation due to dislocation.There is no additional information available at the time of this report.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Suggested component code: mechanical (g04) ¿ head.Visual examination of the provided picture identified the explanted head and stem covered in bio-debris.No further evaluation could be made from the provided picture.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.As per ifu, only authorized combinations of zimmer and biomet products should be used.The use of a non-zb liner is considered off-label use.It is unknown if the off-label use caused or contributed to reported event.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.

• Brand Name: VERSYS FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Common Device Name: PROSTHETIC, 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20466566
• Report Number: 0002648920-2024-00325
• Device Sequence Number: 7519597
• Product Code: LPH
• UDI-Device Identifier: 00889024144736
• UDI-Public: (01)00889024144736(17)250630(10)63096760
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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): 01/10/2025

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: Lay User/Patient
• Device Expiration Date: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 00801803603
• Device Lot Number: 63096760
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2015
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK LINER.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose