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

Catalog Number	00630505840
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post-hip revision, the patient underwent a hip revision due to anterior dislocation.Surgeon increased neck/head length for further stability.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: unknown corin stem.G2: foreign - event occurred in australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; h2; h3; h4; h6; h10.Complaint is not confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.However, it is noted the zb acetabular components were used with a competitor stem.Zimmer biomet has not confirmed the compatibility for these combinations of devices.Please note, as per the instructions for use, it states "only authorized combinations should be used." and "zimmer biomet has not tested the safety or effectiveness of these devices for use in combination with non-zimmer biomet products or components.If surgeons elect to assemble and implant a construct that includes components not manufactured or distributed by zimmer biomet or its affiliates, they do so in reliance on their own clinical judgment and should so inform their patients." 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.

• Brand Name: TRILOGY LONGEVITY
• 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: 25497535
• Report Number: 0001822565-2026-01894
• Device Sequence Number: 10553123
• Product Code: LPH
• UDI-Device Identifier: 00889024123878
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K003478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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): 09/21/2026

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: Lay User/Patient
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: 00630505840
• Device Lot Number: 64538564
• Was Device Available for Evaluation?: No
• 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: 05/19/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 06/14/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Unknown