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

Model Number 200-73-09

Device Problems Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 07/06/2017

Event Type  Injury  

Event Description

It was reported via the legal department that on (b)(6)2013, the patient underwent a right total knee arthroplasty.On (b)(6)2017, approximately 4 years 3 months after implant, the patient underwent revision of the right exactech knee device secondary to complete polyethylene liner wear resulting in osteolysis, metallosis, and synovitis.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

Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer,metal,polymer.Concomitant medical products:¿1474478 230-03-03 - optetrak asy,cr cemented femoral, sz 3, 2493431 204-04-32 - trapezoid tibial tray sz 3f/2t, 2534634 200-02-35 - three peg patella 35mm.Pending investigation.

Manufacturer Narrative

H6: investigation results - the revision reported may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, instability, or any combination of these possibilities, which led to wear of the polyethylene insert.However, this cannot be confirmed as the devices were not returned for evaluation and images of the explanted devices and pre-revision radiographs 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: 16640634
• MDR Text Key: 312281128
• Report Number: 1038671-2023-00545
• 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: 11/15/2023

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 Expiration Date: 01/05/2023
• Device Model Number: 200-73-09
• Device Catalogue Number: 200-73-09
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 11/15/2023
• 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: Female