MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY BONE SCR 6.5X30; PROSTHESIS, HIP

Catalog Number	00625006530
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a total hip procedure, the screws that were implanted to fix the cup fractured during implantation.The screw heads broke off and the screws could no longer be extracted.The threaded portions have been retained by the patient.Due diligence is in progress for this event; to date no additional information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown continuum multihole cup: catalog#ni, lot#ni; trilogy bone scr 6.5x20: catalog#00625006520, lot#66948761.G2: foreign: germany.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d4; d9; g3; h2; h3; h4; h6; h10; h11.Visual examination of the returned products identified returned fractured screw proximal ends.Screw heads show damage and signs of use on the taper below the head.One screw shows gouges and damage to the outer head diameter and taper.No other damage was noted.The second screw shows witness mark on the taper below the head from use.No other damage was noted.Head diameters measured within limits.Optical images from the fracture analysis of both screw fracture surfaces exhibit rotational river lines and hinge artifacts suggesting that both the screws possibly fractured due to torsional overload.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Complaint sample was evaluated and the reported event was 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 event information at time of this report.

• Brand Name: TRILOGY BONE SCR 6.5X30
• 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: 22536102
• Report Number: 0001822565-2025-02589
• Device Sequence Number: 18125653
• Product Code: LPH
• UDI-Device Identifier: 00889024119826
• UDI-Public: (01)00889024119826(17)331116(10)J7663254
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: Health Professional
• Device Catalogue Number: 00625006530
• Device Lot Number: J7663254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown