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

Catalog Number	00875304601
Medical Device Problem Codes	Positioning Failure (1158); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).E1: phone number: (b)(6).G2: foreign ¿ china.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.
Event or Problem Description
It was reported that during the procedure; the 28 mm liner could not be implanted into the size ff/46 cup.After several attempts, the liner would not implant and the cup was loosening.The first cup was removed and a larger cup implanted.A 32 mm liner was attempted to be used and would not implant.A ceramic liner was able to be used to complete the procedure.There was a 30-minute delay.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available 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: d9; g3; h2; h3; h6; h10.Visual examination of the returned product identified the shell was returned with lot 66458964 liner firmly seated within it.The top flat surface of the shell has nicks and scratches, the internal thread has nicks.The outside of the high wall for lot 66458964 liner has indentations, gouges and scratches.The top flat surface and o.D.Visible through the shell¿s threaded hole have indentations, the i.D.Has nicks and scratches.Lot # 66521546 liner has gouges and scratches on the outside of the high wall, the i.D.Has nicks and scratches present.No other damage was noted review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.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 IT
• 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: 22963931
• Report Number: 0001822565-2025-03252
• Device Sequence Number: 13045757
• Product Code: JDI
• UDI-Device Identifier: 00889024150119
• UDI-Public: (01)00889024150119(17)340302(10)66508338
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00875304601
• Device Lot Number: 66508338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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
• Patient Sex: Unknown