MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 3, 9MM, SLOPE ++; SEE H10

Model Number 200-73-09

Device Problem Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

Procodes: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: 2545998 200-02-38 - three peg patella 38mm; 2410965 204-04-33 - trapezoid tibial tray sz 3f/3t; 1524883 230-03-03 - optetrak asy,cr cemented femoral, sz 3.Pending investigation.

Event Description

It was reported via the legal department that on january 17, 2013, the patient underwent a right total knee replacement.On (b)(6) 2017, approximately 4 year 5 months after implant, the patient then had a revision of the exactech knee device secondary to right total knee arthroplasty failure due to polyethylene liner wear with resulting metallosis and aseptic loosening.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.

Manufacturer Narrative

H6: investigation results - the revision reported may have been the result of polyethylene liner wear resulting in metallosis and aseptic loosening as stated in the legal documentation.The wear may have been the result of overall posterior slope of the tibial insert and/or patient related conditions, which allowed for excessive posterior contact.The metallosis may have been due to metal on metal contact between the femoral component and tibial tray as a result of the polyethylene wear.The aseptic (non-infected) loosening may have been the result of an insufficient bond between the implant and the bone.However this cannot be confirmed as the devices were not returned for evaluation, and radiographs, photographs, and operative notes were not provided.

• Brand Name: CR TIBIAL INSERT SZ 3, 9MM, SLOPE ++
• Type of Device: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16640799
• MDR Text Key: 312283001
• Report Number: 1038671-2023-00546
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862041258
• UDI-Public: 10885862041258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2014
• Device Model Number: 200-73-09
• Device Catalogue Number: 200-73-09
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0019-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male