MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TRILOGY LONGEVITY; PROSTHESIS, HIP

Catalog Number	00631005032
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
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 the liner failed to lock into place in the cup.When the implant was opened, the locking ring was detached from the cup and then repositioned into the cup after confirming it was not damaged.The proper position of the ring was confirmed and then the liner was tapped but failed to lock into place.The liner was removed and upon retrying, the ring still failed to lock the liner and the ring subsequently fractured.A new cup and liner were used to complete the procedure.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 products identified the liner shows gouges, indentations, and deformation damage to both inner and outer spherical surfaces, rim, anti rotation scallops, and polar boss.A crack from the rim down into the spherical surface is present.Shell was returned without the lock ring installed in the lock ring groove and was not returned for evaluation.Outer spherical surface shows debris in tm.Inner spherical surface, rim face, and lock ring groove show damage from attempted use.Damage includes gouges, indentations, and scratches to all listed areas.The liner overall diameter, and rim thickness were measured and found to be conforming.Overall diameter for the shell was measured and found to be conforming.The ring was not returned with the devices, therefore further 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.This 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 LONGEVITY
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22809625
• Report Number: 0002648920-2025-00218
• Device Sequence Number: 7798690
• Product Code: LPH
• UDI-Device Identifier: 00889024124721
• UDI-Public: (01)00889024124721(17)280510(10)65963734
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K990135
• 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): 11/13/2025

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: 00631005032
• Device Lot Number: 65963734
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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
• Patient Sex: Unknown