MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY BONE SCR 6.5X20; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Catalog Number	00625006520
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a total hip arthroplasty, a piece of metal broke off while inserting a screw, and the surgery was completed with another screw.The event occurred intra-operatively during screw insertion and caused a surgical delay of approximately 10 minutes.No metallic fragment remained in the patient.The patient had no consequences or impact.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in japan.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d4; d9; g3; h2; h3; h4; h6 visual examination of the returned product identified hex shows nicks and gouges from use."z" etch is present.Taper below head, head underside, and threads show witness marks from insertion.Screw is confirmed fractured around the head outside diameter and part of head outer diameter remains attached and deformed upwards.Fractured fragment was returned for evaluation with the device.No other damage was noted.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.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
No further information at the time of this report.

• Brand Name: TRILOGY BONE SCR 6.5X20
• 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: 25174788
• Report Number: 0001822565-2026-01579
• Device Sequence Number: 13392819
• Product Code: LPH
• UDI-Device Identifier: 00889024119802
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00625006520
• Device Lot Number: J8035428
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2026
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2025
• 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
• Patient Sex: Male