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

Catalog Number	00631005632
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat#: 00877703203, lot#: 3120605, bioloxâ® option, head.G2: foreign: 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 approximately nine months post-hip surgery, the patient underwent a right hip revision due to greater trochanter fracture and abductor deficiency, a large tear was noted.During the procedure, there was trunnionosis on the stem trunnion.The cup and stem were retained and a constrained liner placed.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: b7; d4; g3; h2; h3; h4; h6; h10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: greater trochanter fracture & abductor deficiency (large tear noted); stem found well fixed, retained.Removed ceramic head and found trunnionosis.Scar tissue removed, cultures sent (no results 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 report 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 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: 24052224
• Report Number: 0001822565-2026-00150
• Device Sequence Number: 15819019
• Product Code: LPH
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K990135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/16/2026
• Device Catalogue Number: 00631005632
• Device Lot Number: 64999470
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Male