MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FB SZ 3 LT 8MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-21-23
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994); Scar Tissue (2060); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a left total ankle arthroplasty on (b)(6) 2019 , and then experienced revision surgical procedure on (b)(6) 2023 approximately 3 years and 11 months after initial implant.No images were provided.There is no device information provided.There is no other information available.
Additional Manufacturer Narrative
H10.There is no additional information available.Pending investigation.
Additional Manufacturer Narrative
" d10339764 351-91-04 - saw-10x75x1.19-stryker 371714 351-91-03 - recip sawblade 8x50x1mm 5896945 350-01-03 - talar implant sz 3 lt 6011872 350-11-03 - tibial plate fb sz 3 lt 6179246 350-10-03 - ankle sz 3 locking clip 6222413 351-90-21 - 3.5" pin pouch multiple mdr reports were filed for this event, please see associated reports: xxx, yyyy.This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 the following sections were corrected: h6 the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and/or instability.The reported prosthesis wear and instability could not be confirmed.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, radiographs, and relevant clinical information 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 3 LT 8MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19010031
• Report Number: 1038671-2024-00697
• Device Sequence Number: 20872027
• Product Code: HSN
• UDI-Device Identifier: 10885862276315
• UDI-Public: 10885862276315
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 350-21-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Unknown