MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT MB SZ 1 RT 6MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number TIBIAL INSERT MB SZ 1 RT 6MM

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products - taluskappe 1, re (cat# 350-02-01e / serial# (b)(6)) - tibiaplateau mobil 3, re (cat# 350-32-03 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported by the germany competent authorities after sprain trauma on the right foot, the polyethylene inlay of the endoprosthesis fractured (secured intraoperatively).In the august 2022 notice from the company about a lack of oxidation barrier in the packaging with the possible consequence of inlay damage when stored > 5 years.Although in germany there are no inlays with one if the implant has been implanted for a storage period of > 5 years, this notification is made as a precautionary measure.

• Brand Name: TIBIAL INSERT MB SZ 1 RT 6MM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: miguel soza
• MDR Report Key: 18739417
• MDR Text Key: 335759361
• Report Number: 1038671-2024-00266
• Device Sequence Number: 1
• Product Code: HSN
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TIBIAL INSERT MB SZ 1 RT 6MM
• Device Catalogue Number: 350-42-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2017
• 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-0024-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female