MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT MB SZ 3 RT 6MM; ANKLE ARTHROPLASTY IMPLANTATION SYSTEM

Catalog Number 350-42-03

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

H3: pending investigation.

Event Description

As reported, after implantation of a cementless ankle joint endoprosthesis on (b)(6) 2020, excessive inlay wear and bone cysts on the tibia and talus were found.In (b)(6) 2022, the company reported missing oxidation barrier of the packaging with the possible consequence of inlay damage when stored for > 5 years.Although no inlays that have been stored for > 5 years have been implanted in germany, the report is made precautionary.

Manufacturer Narrative

H3: the revision reported was likely the result of prosthesis wear and osteolysis.The extent and root cause of the prosthesis wear and osteolysis could not be determined as the devices were not returned for evaluation, and images were not provided.

• Brand Name: TIBIAL INSERT MB SZ 3 RT 6MM
• Type of Device: ANKLE ARTHROPLASTY IMPLANTATION SYSTEM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18682414
• MDR Text Key: 335071223
• Report Number: 1038671-2024-00196
• Device Sequence Number: 1
• Product Code: OYK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K152217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 350-42-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female