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

Model Number	350-22-02
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Implant Pain (4561); Insufficient Information (4580); Joint Impingement (4834)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported by the legal brief, patient received a recall notice for his ankle prosthesis manufactured by exactech letter dated (b)(6) 2022.Patient surgery was on june 14, 2019.
Event or Problem Description
As reported by the legal brief, patient received a recall notice for his ankle prosthesis manufactured by exactech letter dated (b)(6), 2022.Patient implant surgery was on (b)(6)2019; he alleges he sustained injury.No additional information available.
Additional Manufacturer Narrative
Section h10: (h3) 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 this event cannot be conclusively determined; insufficient information.Section h11: the following sections have corrected information: (b5) as reported by the legal brief, patient received a recall notice for his ankle prosthesis manufactured by exactech letter dated april 11, 2022.Patient implant surgery was on (b)(6) 2019; he alleges he sustained injury.No additional information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d6a, h6.Mdr section codes updated/corrected: a, b, c, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of joint impingement and pain as reported.Additional reasons for revision may be due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.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 RT 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14781850
• Report Number: 1038671-2022-00712
• Device Sequence Number: 12207156
• Product Code: HSN
• UDI-Device Identifier: 10885862276346
• UDI-Public: 10885862276346
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/09/2025

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: 350-22-02
• Device Catalogue Number: 350-22-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 08/24/2022; 01/08/2025; 09/08/2025
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 09/15/2022; 01/10/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2019
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male