MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM MOD HEAD COCR -3MM NECK; PROSTHESIS, HIP

Catalog Number	163668
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; h2; h3; h4; h6; h10.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.A definitive root cause cannot be determined.However, the liner was implanted in (b)(6) 2024 but had an expiration date of jan of 2024, it is unknown if this caused or contributed to the reported event.This complaint cannot be confirmed for the reported dislocation but can confirm for the use of expired product.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4) d10: biomet devices 11-300818 arcos 18x150mm spl tpr dist 65886065, 11-301324 arcos con sz d std 70mm 407970.G2 foreign: australia.H6 proposed component code: mechanical (g04) - head.The device will not be returned for analysis, as the device was requested but not returned by hospital; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported the patient had primary hip arthroplasty.Subsequently, patient was revised approximately 6 (six) months later due to dislocation.The head, liner, stem and cone body were removed and replaced.

• Brand Name: 32MM MOD HEAD COCR -3MM NECK
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22449450
• Report Number: 0001825034-2025-02017
• Device Sequence Number: 15552256
• Product Code: JDG
• UDI-Device Identifier: 00887868308321
• UDI-Public: (01)00887868308321(17)300811(10)64850340
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K942479
• 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,Followup
• Report Date (Section B): 08/29/2025

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: 163668
• Device Lot Number: 64850340
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male