MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. MULTIPOLAR SHELL 49 MM O.D.; PROSTHESIS, HIP

Catalog Number	00500104900
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure 2 and a half months post implantation due to recurrent dislocation.The patient's initial dislocation occurred after the primary surgery when no medical intervention was performed.There is no additional information available.
Additional Manufacturer Narrative
(b)(4).Event previously reported under mfr #0001822565-2025-00200 and mfr#0001822565-2025-00201.It was determined that the head and liner did not dislocated, it was the shell from the natural acetabulum.G2: foreign: australia.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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.This complaint cannot be confirmed.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: MULTIPOLAR SHELL 49 MM O.D.
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21976115
• Report Number: 0002648920-2025-00128
• Device Sequence Number: 7265590
• Product Code: KWY
• UDI-Device Identifier: 00889024115415
• UDI-Public: (01)00889024115415(17)330213(10)65840253
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K833991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 05/06/2025

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 Catalogue Number: 00500104900
• Device Lot Number: 65840253
• 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: 04/23/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Unknown