MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FB SZ 4 LT 6MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 350-21-04

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 11/30/2022

Event Type  Injury  

Manufacturer Narrative

Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of surgical revision for pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.

Event Description

It was reported by the legal department, that this male patient had an ankle revision due to the recall.Patient stated they were experiencing pain within a few months.No additional information is available.

Event Description

As reported via legal documentation the patient had a left ankle replacement on (b)(6)2021.Approximately 11 months after the initial procedure the patient had a left ankle revision on (b)(6) 2022.Revision op report on (b)(6) 2022.Diagnosis: failed left total ankle arthroplasty.Patient was revised to competitor's devices.A significant amount of synovial fluid to be present.The surgeon was able to remove the previous advantage total ankle arthroplasty in entirety without difficulty."the implant was noted to be fairly well, but it was not real difficulty to remove it." there is no indication for surgery provided in the revision operative report.There is no mention of any device malfunction/wear or infection.New implants were trailed and then placed."no additional procedures were required." the patient was transferred to post anesthesia care.There is no other patient demographic or medical history available.There are no photos or other images of the device provided.No additional information is available.

Manufacturer Narrative

D10.Concomitants: 350-01-04 - talar implant sz 4 lt, sn: (b)(6).350-10-04 - ankle sz 4 locking clip, sn: (b)(6).350-11-04 - tibial plate fb sz 4 lt, sn: (b)(6).H3.Investigation results-the tibial insert fb sz 4 lt 6mm device with serial number: (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.There is no indication for surgery provided in the revision operative report.There is no mention of any device malfunction/wear or infection.These devices are used for treatment not diagnosis.

• Brand Name: TIBIAL INSERT FB SZ 4 LT 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16036256
• MDR Text Key: 306019856
• Report Number: 1038671-2022-01621
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 350-21-04
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• 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
• Treatment: SEE H10.; UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male