MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY 52MM O.D. SIZE II POROUS UNCEMENTED CLUSTER HOLES SHELL; PROSTHESIS, HIP

Catalog Number	00875305201
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 surgery the liner and cup would not mate.The surgeon made several attempts by hitting it, resulting in the loosening of the cup.A new cup and liner were used, and the surgery was completed successfully.There was no known impact or consequences to the patient.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; d5; d9; g3; h2; h3; h4; h6.Visual examination of the returned product identified shell has scratches and gouges to the internal taper and anti-rotation radii surfaces.Internal bottom diameter and top flat surfaces have scratches all over.Internal threads have nicks and gouges on both ends.No other damage was noted.Where measured, the device was conforming to specifications.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.This complaint cannot be 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
No further information at the time of this report.

• Brand Name: TRILOGY 52MM O.D. SIZE II POROUS UNCEMENTED CLUSTER HOLES SHELL
• 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: 21604580
• Report Number: 0001822565-2025-00615
• Device Sequence Number: 4374992
• Product Code: JDI
• UDI-Device Identifier: 00889024150171
• UDI-Public: (01)00889024150171(17)340209(10)66337959
• 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): 07/17/2025

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: 00875305201
• Device Lot Number: 66337959
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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