MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE H; PROSTHESIS, KNEE

Model Number 42-5300-083-01

Device Problems Unstable (1667); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 06/02/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial total knee arthroplasty.Subsequently, approximately three (3) months post-implantation, the patient experienced mid-flexion instability due to excessive internal rotation and misalignment of the tibial tray.All components were removed and replaced with a competitor system without complication.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).D10: medical product: femur trabecular metal cruciate retaining (cr) standard porous: catalog#42502807001, lot#64592443; articular surface fixed bearing cruciate retaining (cr) left 10 mm height: catalog#42512000610, lot#64528771.G2: foreign: australia.The customer has indicated that the product will not be returned to zimmer biomet for evaluation as it was discarded as biohazard.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The provided pictures were insufficient to complete visual or dimensional evaluation of the product.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.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.

Event Description

No further event information available at the time of this report.

• Brand Name: NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE H
• Type of Device: PROSTHESIS, KNEE
• 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: 17198207
• MDR Text Key: 317823536
• Report Number: 0001822565-2023-01686
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024510616
• UDI-Public: (01)00889024510616(17)291231(10)64517554
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K173417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

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
• Device Operator: Health Professional
• Device Model Number: 42-5300-083-01
• Device Catalogue Number: 42530008301
• Device Lot Number: 64517554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 130 KG