MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Catalog Number	00625006515
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Aseptic loosening (4883)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left hip revision due to pain, ambulation difficulties, and acetabular fixation failure.The patient reported severe pain and they were unable to walk.The stem was retained and all other components revised.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).A2: date of birth in 1953.D6a: implanted in 2025.D10: cat# # 320788 bioloxâ® delta ceramic taper liner cat# 00877503201 lot# 3234103 bioloxâ® delta, ceramic femoral head g2: foreign ¿ event occurred in south korea.The product has been received by zimmer biomet and the investigation is in process.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: TRILOGY
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
• 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: 24926212
• Report Number: 0001822565-2026-01325
• Device Sequence Number: 21499734
• Product Code: LPH
• UDI-Device Identifier: 00889024119796
• UDI-Public: (01)00889024119796(17)350114(10)J7894338
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2026

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: 00625006515
• Device Lot Number: J7894338
• Date Returned to Manufacturer: 04/15/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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 Sex: Female
• Patient Weight: 88 LB
• Patient Race: Asian