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

Catalog Number	11-363665
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); High metal ion levels (4847)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately five years post-hip surgery, the patient underwent a right hip revision due to trunnionosis.The patient presented with pain; elevated cobalt and chromium levels; and difficulty walking.During the revision, corrosive trunnionosis was identified on the head and trunnion; the joint was void of abductor attachment; and fibrinous and necrotic tissue was debrided.The stem and shell were stable and left in tact.A new head, liner, and locking ring were placed.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).H6: suggested component code: mechanical (g04) - head.The device will not be returned for analysis; 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
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: g3; h2; h3; h6; h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: failed tha secondary to metal allergy and trunnionosis with metal ion release.Significant amount of fluid released from the joint.Significant amount of fibrinous and necrotic tissue debrided.Greater trochanter was completely balded and void of any abductor attachment.Femoral stem found well-fixed under stress.Corrosive trunnionosis noted on the trunnion and femoral head.The liner was removed and the locking ring was damaged in the process, therefore this was also removed.Shell well-fixed and left intact.Trunnion cleaned and dried and a new head was applied.Copious irrigation performed.Drain placed, joint closed, and no intraoperative complications were identified.A definitive root cause cannot be determined.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: BIOMET HIP SYSTEM
• 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: 23821054
• Report Number: 0001825034-2025-04005
• Device Sequence Number: 10098875
• Product Code: JDI
• UDI-Device Identifier: 00887868307980
• UDI-Public: (01)00887868307980(17)250826(10)167810
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K032396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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 Expiration Date: 08/26/2025
• Device Catalogue Number: 11-363665
• Device Lot Number: 167810
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2015
• 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