MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM COCR MOD HD -6MM; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Failure of Implant (1924); Crepitus (4893)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 010000662, g7 pps ltd acet shell 50d, (b)(6).010000739, g7 neutral arcomxl lnr 36mm d, (b)(6).104209, mallory head fem hap 9x150mm, (b)(6).G2: foreign: australia.Proposed component code: mechanical- head (g04).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip arthroplasty and was implanted with zimmer biomet products.Subsequently, the patient was revised seven (7) years post implantation due to malposition of the cup and the trunnion of the stem sitting inferior of the cup.The head, cup, and liner were explanted.The patient was implanted with competitor products.Diligence for additional information is ongoing.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: d4, g3, g6, h2, h3, h4, h6, h10.Visual examination of the provided pictures identified the explanted devices, bio-debris present.Devices not returned, further analysis cannot be made.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: 36MM COCR MOD HD -6MM
• Common Device Name: PROSTHESIS, HIPS
• 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 ; .; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21943903
• Report Number: 0001825034-2025-01290
• Device Sequence Number: 21096339
• Product Code: JDI
• UDI-Device Identifier: 00880304210509
• UDI-Public: (01)00880304210509(17)270124(10)632100
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 08/07/2025

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 Model Number: N/A
• Device Catalogue Number: 11-363660
• Device Lot Number: 632100
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2017
• 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: Female