MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL PLATE; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	ANKLE COMPLAINTS
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal brief, on or about (b)(6) 2018, patient underwent a right total ankle arthroplasty due to end-stage arthritis with associated equinus contracture and persistent pain associated with previous ankle hardware.On or about (b)(6) 2019, patient underwent right ankle revision due to a failed right total ankle replacement.Surgeon indicated in his operative report that the patient's "clinical exam and radiographs demonstrated loosening of the tibial component." during the patient's right total ankle revision surgery on or about (b)(6) 2019, surgeon performed a revision of the patient's right ankle arthoplasty and implanted a competitor's ankle components.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the revision reported in case was likely the result of an insufficient bond between the tibial plate and the bone, patient-related conditions, or a combination of the two, which led to aseptic (non-infected) tibial loosening.However, this cannot be confirmed as devices were not available for evaluation and images of the explanted devices, pre-revision radiographs, and operative were not provided.
Additional Manufacturer Narrative
Additional information: d1, d4 all, g4 510k, h4.These devices are used for treatment not diagnosis.

• Brand Name: TIBIAL PLATE
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16092514
• Report Number: 1038671-2023-00003
• Device Sequence Number: 6703713
• Product Code: HSN
• UDI-Device Identifier: 10885862276193
• UDI-Public: 10885862276193
• Combination Product (Y/N): N
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ANKLE COMPLAINTS
• Device Catalogue Number: 350-12-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 12/13/2022; 05/31/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 05/30/2023; 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2018
• 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
• Patient Sex: Male