MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY LONGEVITY LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM I.D.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Dislocation (2374); Osteolysis (2377)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: italy.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip procedure on an unknown date where competitor product was implanted.Subsequently, approximately 11 (eleven) years later, the patient undergoes a revision of competitor product where a zimmer biomet cup, liner and head are implanted.During the post operative period in the hospital, the cup and liner disassociates.The patient undergoes a second revision approximately 1 (one) week later to fix the liner and cup.During the revision, the surgeon is unable to mate the liner with the cup.The liner and cup are explanted leading to major bone loss for the patient.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: g3; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided for the liner.Medical records were not provided.A definitive root cause cannot be determined.It was noted the rep stated a 15 degree shoulder liner was implanted, however it is unknown if they meant a liner for the shoulder or a language barrier of a high wall liner.It is also unknown if the products were damaged when attempting to reassemble.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d1; d2; d4; g3; g4; h2.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d4; g3; h2; h3; h4; h6 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.Medical records were not provided.A definitive root cause cannot be determined.It was noted the rep stated a 15-degree shoulder liner was implanted, however it is unknown if they meant a liner for the shoulder or a language barrier of a high wall liner.It is also unknown if the products were damaged when attempting to reassemble.This complaint cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further information at the time of this report.

• Brand Name: TRILOGY LONGEVITY LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM I.D.
• 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: 19173415
• Report Number: 0001822565-2024-01394
• Device Sequence Number: 12747283
• Product Code: JWH
• UDI-Device Identifier: 00889024124813
• UDI-Public: (01)00889024124813(17)280812(10)66136169
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K972774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup,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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00631005836
• Device Lot Number: 66136169
• 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: 04/03/2024
• Supplement Date Received by Manufacturer: 09/19/2024; 12/12/2024; 04/29/2025
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 09/24/2024; 12/12/2024; 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN STEM.; UNKNOWN ZIMMER BIOMET HEAD.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male