MAUDE Adverse Event Report: EXACTECH, INC. ANKLE SZ 4 LOCKING CLIP; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-10-04
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: (b)(6), 350-01-05 - talar implant - sz 5 - l; (b)(6), 350-11-04 - tibial plate fb sz 4 lt; (b)(6), 351-50-00 - model tibia talus report; (b)(6), 351-90-21 - 3.5" pin pouch; (b)(6), 351-90-21 - 3.5" pin pouch; (b)(6), 351-90-22 - 2.5" pin pouch; (b)(6), 351-90-24 - talar trial screw pouch; (b)(6), 351-91-03 - recip sawblade 8x50x1mm; (b)(6), 351-91-04 - saw-10x75x1.19-stryker.H3: the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that this patient's left ankle was revised approximately 2 years 2 months post initial operation.Original locking clip broke.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Corrected fields: b2, b3, d6b.Additional information fields: b5, g3, h6 clinical codes.
Event or Problem Description
It was reported that approximately 27 months after a left total ankle replacement procedure, the patient underwent a revision surgery to address pain and ambulation difficulties.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d6b, h6 mdr section codes updated/corrected: a, b, c, d, e the revision reported was likely due to fracture of both the insert and locking clip, and disassembly of the locking clip, which led to prosthesis wear of the metal components.However, based on limited information provided, the reported prosthesis wear and sequence of events could not be confirmed.Additionally, potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: ANKLE SZ 4 LOCKING CLIP
• 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; 2320 nw 66th court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21312503
• Report Number: 1038671-2025-00651
• Device Sequence Number: 8243889
• Product Code: HSN
• UDI-Device Identifier: 10885862302021
• UDI-Public: 10885862302021
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 09/04/2025

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: 350-10-04
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 02/05/2025; 09/03/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 02/11/2025; 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male