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

Catalog Number	350-12-03
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study, that the 78 yo male patient had x-rays that showed a progression of tibial component subsidence into the anterior tibia and a suggestion of loosening of tibial component.The date of adverse event onset is (b)(6) 2020.The provider recommended revision to implant with stemmed tibial component.Patient was revised on (b)(6) 2021 with exactech components.The patient¿s outcome was last known as resolved.
Additional Manufacturer Narrative
Concomitant medical product(s): serial #: (b)(4), category #: 350-22-63 - tibial insert fb sz 3 rt 12mm, the serial number (b)(4) is not affected by the recall.Serial #: (b)(4), category #: 350-02-03 - talar implant sz 3 rt, serial #: (b)(4), category #: 350-10-03 - ankle sz 3 locking clip.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: b3, d1/d2a/d2b, h6.Mdr section codes updated/corrected: a, b, c, d, e, f, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of tibial loosening and subsidence.The reported tibial loosening and subsidence 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 PLATE FB SZ 3 RT
• 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 FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16560010
• Report Number: 1038671-2023-00454
• Device Sequence Number: 5729317
• Product Code: HSN
• UDI-Device Identifier: 10885862276193
• UDI-Public: 10885862276193
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 350-12-03
• 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: 02/17/2023
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2016
• 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: Other; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White