MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FB SZ 4 LT 7MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-21-14
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: "(b)(6) 350-11-04 - tibial plate fb sz 4 lt, (b)(6) 350-10-04 - ankle sz 4 locking clip, (b)(6) 350-01-04 - talar implant sz 4 lt, (b)(6) 351-91-03 - recip sawblade 8x50x1mm, (b)(6) 351-91-04 - saw-10x75x1.19.The product associated with the reported event is within the scope of recall z-0024-2022.However, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case ¿ usa.It was reported that approximately 29 months after a left total ankle replacement procedure, the patient underwent a revision procedure to address prosthesis wear, loose left ankle total arthroplasty.Revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.The serial number: (b)(6) is confirmed to be a part of recall number: z-0024-2022.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of loosening, prosthesis wear and/or 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.H6: corrected health effect and investigation clinical codes.

• Brand Name: TIBIAL INSERT FB SZ 4 LT 7MM
• 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20402693
• Report Number: 1038671-2024-03875
• Device Sequence Number: 3378973
• Product Code: HSN
• UDI-Device Identifier: 10885862276285
• UDI-Public: 10885862276285
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 01/23/2025

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 Expiration Date: 12/14/2025
• Device Catalogue Number: 350-21-14
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 01/23/2025
• Date Device Manufactured: 12/15/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown