MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY LONGEVITY LINER 20 DEGREE ELEVATED RIM 32 MM I.D.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a hip procedure.Subsequently, the patient underwent a third revision approximately 14 years later due to instability and chronic periprosthetic fracture.During the revision, the surgeon noted that the cerclage wires had all essentially failed with several from the initial fixation found broken.The plate and all cables were removed, and a trochanteric bolt was placed along with new cerclage wires for fixation.The head and liner were also exchanged without complication.The patient continued to experience nonunion following the revision.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign: canada.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
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no related deviations or anomalies during manufacturing.Findings: chronic periprosthetic fracture left femur.All wires used in the past ¿had all essentially failed¿.Several broken wires from original fixation removed ¿ manufacturer unknown.Femoral head removed, positioned the trunnion posterior to the cup.Capsular tissue, which was acting as a tether, was released, ¿after releasing an appropriate amount of scar, able to pull the fragment down with the leg held in slight abduction and internal rotation.¿ irrigation performed.X-ray review is satisfactory with no changes, fragment remains reduced and has not changed position.Intramuscular lesion anterior aspect of the left thigh adjacent to the revised tha.Although nonspecific, given presence of a revised joint prosthesis, this is favored to represent recurrent foreign body reaction/trunnionosis.¿revision left tha with cerclage wire and trochanteric screw fixation.Fracture of the cerclage wire.Resorption and bony deficiency about the left greater trochanter with slight distraction.¿ a definitive root cause cannot be determined.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.

• Brand Name: TRILOGY LONGEVITY LINER 20 DEGREE ELEVATED RIM 32 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: 19606026
• Report Number: 0001822565-2024-02124
• Device Sequence Number: 6334913
• Product Code: LPH
• UDI-Device Identifier: 00889024125551
• UDI-Public: (01)00889024125551(17)250228(10)64610406
• 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: 2008
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2024

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: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 00632005032
• Device Lot Number: 64610406
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 07/09/2024; 11/19/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/16/2024; 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2020
• 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: Female
• Patient Weight: 55 KG
• Patient Race: White