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

Catalog Number	163660
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 110030998, lot# 67151395 bearing 28 mm i.D.40 mm o.D.Size d.G2: foreign - event occurred in ecuador.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
It was reported that approximately six weeks post-implantation, the patient underwent a closed reduction due hip dislocation.The patient suffered two previous dislocations and the latest occurred when they were lying in bed and turned onto their hip.The hip was reduced under general anesthesia without difficulty.Following the procedure, when performing tractions, there was some subluxation, so the hip was immobilized to not flex the hip.The following day, it was re-evaluated and the thigh was lifted without problem or pain.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6; h10.The following sections were corrected: h6 impact code.Visual examination of the provided pictures identified what appears to be the patient's bone from the initial surgery.No further evaluation can be made.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty with superolateral dislocation of the femoral component including the polyethylene.Of note, the femoral offset is asymmetrically decreased on the right which can predispose to instability a definitive root cause cannot be determined for the dislocation between the bearing and dm liner.No problem was found with the femoral head, as it remained assembled to the bearing based on the provided information.If the hip was able to be reduced correctly with closed reduction, the head is still assembled to the bearing.Complaint is 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 further information is available at the time of this report.

• 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: 24032912
• Report Number: 0001825034-2026-00097
• Device Sequence Number: 21429618
• Product Code: LPH
• UDI-Device Identifier: 00887868308253
• UDI-Public: (01)00887868308253(17)350811(10)J7996233
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K990830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

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: 163660
• Device Lot Number: J7996233
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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 Age: 40 YR
• Patient Sex: Male
• Patient Weight: 76 KG