MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY LONGEVITY LINER STANDARD 3.5 MM OFFSET 36 MM; PROSTHETIC, HIP

Catalog Number	00630505036
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00620205420 item name shell porous with multi holes 54 mm lot # 61289562 g2: foreign: australia 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 patient underwent a revision procedure 1 year and 4 months post implantation due to the liner fracturing.Both the liner and the shell were explanted.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to have been reported under mfr #0001822565-2025-00410.The initial report was forwarded in error and should be voided.Refer to 0001822565-2025-00410 for the reporting of the event moving forward.
Event or Problem Description
Upon reassessment of the reported event, it was determined to have been reported under mfr #0001822565-2025-00410.The initial report was forwarded in error and should be voided.Refer to 0001822565-2025-00410 for the reporting of the event moving forward.

• Brand Name: TRILOGY LONGEVITY LINER STANDARD 3.5 MM OFFSET 36 MM
• Common Device Name: PROSTHETIC, 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: 21272786
• Report Number: 0001822565-2025-00207
• Device Sequence Number: 19844876
• Product Code: LPH
• UDI-Device Identifier: 00889024123762
• UDI-Public: (01)00889024123762(17)270609(10)65467874
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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: 00630505036
• Device Lot Number: 65467874
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2022
• 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: Unknown