MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY® LONGEVITY LINER 10 DEGREE ELEVATED RIM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00620206220, item name shell porous with multi holes 62 mm, lot # 63647916.G2: foreign: australia.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision procedure 1 year and 2 months post implantation due to a failure of a stryker product that was cemented into the tmars shell.There is no additional information available at the time of this report.
Event or Problem Description
Upon reassessment of the reported event, it was determined that the liner was not reportable as it was not involved in the failure.The initial report was forwarded in error.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that the liner was not reportable as it was not involved in the failure.The initial report was forwarded in error.Sections updated: b4, b5, g3, g6, h2, h10.

• Brand Name: TRILOGY® LONGEVITY LINER 10 DEGREE ELEVATED RIM
• 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: 19499179
• Report Number: 0001822565-2024-01935
• Device Sequence Number: 12465581
• Product Code: LPH
• UDI-Device Identifier: 00889024124912
• UDI-Public: (01)00889024124912(17)240430(10)64376430
• 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 Explanted Year: 2024
• 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): 07/01/2024

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00631006236
• Device Lot Number: 64376430
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2019
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 89 KG