MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FB SZ 2 LT 6MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	TIBIAL INSERT FB SZ 2 LT 6MM
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the 79 y/o female patient had a left ankle replacement on (b)(6) 2022.Approximately 9 months after the initial procedure the patient had a left ankle revision on (b)(6) 2022.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report (b)(6) 2022.Diagnosis: left flatfoot deformity.No complications during the procedure and the patient was stable when sent to the pacu.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: b3, h6.Mdr section codes updated/corrected: a, b, c, d, f, g.The reason for the revision reported cannot be determined from the available information but may have been reported at this later time due to inclusion of one of the implanted devices in the packaging recall.Based on length of implantation, the reason for revision appears unlikely to be secondary to prosthesis wear.However, the reported prosthesis wear could not be confirmed and potential contributions of user, or patient-related considerations to the event could not be assessed as no images or radiographs were provided, relevant clinical information was not provided, and the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TIBIAL INSERT FB SZ 2 LT 6MM
• Common Device Name: 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17073467
• Report Number: 1038671-2023-01259
• Device Sequence Number: 20365978
• Product Code: HSN
• UDI-Device Identifier: 10885862276223
• UDI-Public: 10885862276223
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2025

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
• Operator of Device: Health Professional
• Device Model Number: TIBIAL INSERT FB SZ 2 LT 6MM
• Device Catalogue Number: 350-21-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female