MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FB SZ 3 RT 10MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	TIBIAL INSERT FB SZ 3 RT 10MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4.5 years post initial right taa, the 63 y/o male patient complained of pain.Patient had a recalled poly.Patient was revised with exactech devices.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos and x-rays received.The device is not available for evaluation due to recall hospital will not release device.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: TIBIAL INSERT FB SZ 3 RT 10MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: miguel soza
• MDR Report Key: 18395266
• Report Number: 1038671-2023-03056
• Device Sequence Number: 8724219
• Product Code: HSN
• UDI-Device Identifier: 10885862293275
• UDI-Public: 10885862293275
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/26/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2026
• Device Model Number: TIBIAL INSERT FB SZ 3 RT 10MM
• Device Catalogue Number: 350-22-43
• 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: 12/04/2023
• Initial Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2018
• 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: 2.5" PIN POUCH.; 3.5" PIN POUCH.; ANKLE SZ 3 LOCKING CLIP.; RECIP SAWBLADE 8X50X1MM.; SAW-10X75X1.19-STRYKER.; TALAR IMPLANT SZ 3 RT.; TALAR TRIAL SCREW POUCH.; TIBIAL INSERT FB SZ 3 RT 10MM.; TIBIAL PLATE FB SZ 3 RT.; TUBERCLE PIN POUCH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male