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

Catalog Number	00625006530
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Muscle/Tendon Damage (4532)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately twelve days post-implantation, the patient underwent a right hip revision due to instability and acetabular failure.The patient experienced pain due to a fractured screw.The gluteus muscles had been damaged.The shell and screws were revised.Patient reports the construct fell apart during the procedure.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
There is no further event information 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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records 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: the patient has a history of previous revisions.The patient reported pain and the screw has fractured.The acetabular construct was unstable "fell apart in the surgeon's hands." tissue damage was noted as well.Two screws and the shell were explanted.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: TRILOGY
• 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: 23513903
• Report Number: 0001822565-2025-04057
• Device Sequence Number: 13250529
• Product Code: LPH
• UDI-Device Identifier: 00889024119826
• UDI-Public: (01)00889024119826(17)340412(10)J7748036
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: 00625006530
• Device Lot Number: J7748036
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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: Female
• Patient Weight: 104 KG