MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY BONE SCREW SELF-TAPPING; PROSTHESIS, HIP

Catalog Number	00625006525
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Aseptic loosening (4883)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately three years post-implantation, the patient is being considered for a left hip revision due to loosening of the acetabular triflange component and acetabular bone fracture due to unknown reason.Patient is experiencing pain.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).B3: event date ¿ unknown in 2025.D10: cat: pm0004069 lot: 127540 rocha left triflange sz 26, cat: cp161951 lot: 266680 ti lock-scr cancls, cat: cp161942 lot: 259440 ti lock-scr cancls, cat: cp161943 lot: 162350 ti lock-scr cancls, cat: cp161942 lot: 610480 ti lock-scr cancls, cat: cp161945 lot: 251480 ti lock-scr cancls, cat: cp161941 lot: 170820 ti lock-scr cancls, cat: cp161951 lot: 265550 ti lock-scr cancls, cat: cp161944 lot: 780030 ti lock-scr cancls, cat: cp161941 lot: 529910 ti lock-scr cancls, cat: cp161942 lot: 653860 ti lock-scr cancls.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b2; b3; b5; d4; d6b; 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 not provided.A definitive root cause cannot be determined.Complaint is not 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.
Event or Problem Description
It was reported that approximately three years post-implantation, the patient underwent a left hip revision due to loosening of the acetabular triflange component and acetabular bone fracture due to unknown reason.Patient was experiencing pain.Attempts have been made and no further information has been provided.

• Brand Name: TRILOGY BONE SCREW SELF-TAPPING
• 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: 22826713
• Report Number: 0001822565-2025-02976
• Device Sequence Number: 13142353
• Product Code: LPH
• UDI-Device Identifier: 00889024119819
• UDI-Public: (01)00889024119819(17)320613(10)J7279724
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: 00625006525
• Device Lot Number: J7279724
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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; Other
• Patient Age: 50 YR
• Patient Sex: Female