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

Catalog Number	163669
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient was revised for a second time approximately two years post implantation due to dislocation.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).Proposed component code: mechanical (g04) - head.D10: cat# 192110 lot# 65890680 echo por fmrl lat nc 10x130mm.Cat# 110010246 lot# 66175211 g7 osseoti 4 hole shell 56mm f.G2: foreign: australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; g3; h2; h3; h4; h6.Visual examination of the provided pictures identified a explanted head remains assembled in bearing, and seen covered in biodebris.There is also some black debris seen within the inner surface of the head.A stem is also seen explanted and covered in biodebris.No further observations could be made based on the image alone.No product was returned; further visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.A radiograph image was provided, however could not be further reviewed as image is undated and unable to correlate to the events of dislocation.A definitive root cause cannot be determined.Unable to confirm complaint.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 information at the time of this report.

• Brand Name: BIOMET HIP SYSTEM 32MM MOD HEAD COCR STD 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: 22469189
• Report Number: 0001825034-2025-02033
• Device Sequence Number: 19892340
• Product Code: LPH
• UDI-Device Identifier: 00887868308338
• UDI-Public: (01)00887868308338(17)320819(10)J7322260
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K990830
• 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): 08/27/2025

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: 163669
• Device Lot Number: J7322260
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown