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

Model Number	TIBIAL INSERT FB SZ 2 RT 6MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Failure of Implant (1924); Pain (1994); Joint Impingement (4834)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial ankle replacement on (b)(6) 2018.The patient presented with medial symptoms, mechanical in nature, but related to the superficial peroneal nerve.Radiographs show heterotopic ossification of medial gutter, causing impingement.The patient was revised on (b)(6) 2022, and the tibial insert and locking clip were replaced.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Pending investigation.Medical products: 350-02-02 - talar implant sz 2 rt 5148428, 350-10-01 - ankle sz 1 locking clip 5188250, 350-12-01 - tibial plate fb sz 1 rt 5238976, 351-91-03 - recipsawblade 8x50x1mm 239091.
Additional Manufacturer Narrative
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 surgical revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.H7: z-0024-2022.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, f10 (remove data from initial), g1, h7 (uncheck), h6: clinical code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusions.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that a female patient had a revision surgery for impingement.Indication for initial implant surgery was post traumatic arthritis.Patient had medial symptoms mechanical in nature but related to the superficial peroneal nerve.Radiographs show heterotopic ossification of medial gutter, causing impingement.It is indicated that this is unlikely related to the device and possibly related to the procedure.Tibial insert and tibial locking clip were replaced.Outcome: continuing.No additional information available.

• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15419013
• Report Number: 1038671-2022-01111
• Device Sequence Number: 19529393
• Product Code: HSN
• UDI-Device Identifier: 10885862276346
• UDI-Public: 10885862276346
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/10/2025
• Device Model Number: TIBIAL INSERT FB SZ 2 RT 6MM
• Device Catalogue Number: 350-22-02
• 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: 08/25/2022
• Supplement Date Received by Manufacturer: 09/22/2022; 02/04/2026
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 10/11/2022; 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2017
• 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: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White