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

Catalog Number	00633405028
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374); Osteolysis (2377)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: s&n synergy stem.G2: foreign - event occurred in canada.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
It was reported that the patient experienced a closed reduction and is pending a left hip revision with a triflange due to dislocation, osteolysis, and non-displaced superior and inferior pubic rami fractures.The patient has some instability and the locking mechanism for components apparently failed.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 updated: d4; d10; h2; h3; h4; h6; h10.\ \ d10: s&n synergy stem and s&n head.\ \ complaint is not confirmed.\ \ no product was returned or pictures provided; visual and dimensional evaluations could not be performed.\ \ review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.\ \ review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.\ \ medical records were provided and reviewed.Review identified the following: limited information provided.No part/lot information or official operative records were provided, only progress notes and radiology reports.Emails indicate zb implants are involved and a pmi request for a triflange component.Primary left tha on an unknown date with a history of multiple revisions due to aseptic loosening.No information was provided to indicate what components were revised or when.Left hip dislocated and underwent closed reduction.Severe osteolysis and non-displaced superior and inferior pubic rami fractures were noted.\ \ a definitive root cause cannot be determined; however, there was a competitor stem and head used with a zimmer biomet head.It is unknown if this caused or contributed to the reported event.\ \ 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.
Event or Problem Description
No further information is available at the time of this report.

• Brand Name: TRILOGY LONGEVITY
• 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: 24267988
• Report Number: 0001822565-2026-00418
• Device Sequence Number: 10030773
• Product Code: KWZ
• UDI-Device Identifier: 00889024668881
• UDI-Public: (01)00889024668881(17)291202(10)66950033
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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 Catalogue Number: 00633405028
• Device Lot Number: 66950033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 209 LB