MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER BIOMET CERAMIC HEAD; PROSTHESIS, HIP

Catalog Number	802804003
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Scar Tissue (2060); Medical device site infection (4845)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat: 192113, lot: 696900, echo por fmrl lat nc 13x145mm.Cat: 110010246, lot: 65915639, g7 osseoti 4 hole shell 56mm f.H6: proposed component code: mechanical (g04) ¿ head.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was retained by the hospital.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 approximately one and a half years post-implantation, the patient underwent a hip revision due to infection, pain, inflammation, and head and trunnion disassociation demonstrated on x-rays.During the revision the head was confirmed fractured, there was significant scar tissue, and necrotic tissue was debrided from the cup.All components revised and a cement spacer implanted.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6; h10.Visual examination of the provided pictures identified the broken ceramic head, covered in bio-debris.No further evaluation can be made.Pictures of the other devices were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided.Review of the available records identified the following: radiographs demonstrated head/trunnion dissociation with concern for femoral head fracture.Previous approach utilized, significant scarring noted in the fascial layer to deep tissues.Cultures obtained, necrotic tissue debrided from the cup.The fractured ceramic femoral head was removed with minimal noted ceramic comminution.X-rays assessed, not sent to mmi at this time given the detail provided in the revision op notes.A definitive root cause cannot be determined for the head fracture and disassociation from the stem.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards.Therefore, it is unlikely that the specified device caused any patient infection.Complaint is 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: ZIMMER BIOMET CERAMIC HEAD
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22722618
• Report Number: 0001822565-2025-02797
• Device Sequence Number: 9174107
• Product Code: JDI
• UDI-Device Identifier: 00887868376696
• UDI-Public: (01)00887868376696(17)320831(10)3123307
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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: 802804003
• Device Lot Number: 3123307
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 54 KG