MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TIBIAL PLATE FB SZ 3 RT

Model Number	350-12-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation: concomitant device(s): 350-22-22, (b)(4), tibial insert fb sz 2 rt 8mm, 350-02-02, (b)(4), talar implant sz 2 rt, 351-91-03, (b)(4), recip sawblade 8x50x1mm, 350-10-03, (b)(4), ankle sz 3 locking clip.
Event or Problem Description
Approximately 3 years postop the initial right ankle implant, this (b)(6) male patient experienced tibial loosening and was revised.Patient is doing well now.Removal of vantage implant.The patient has a history of post-traumatic arthritis.No other information available as revision was completed out of the clinical study.Device is not returning.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of an insufficient bond between the implant 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 the devices were not available for evaluation.

• Brand Name: VANTAGE
• Common Device Name: TIBIAL PLATE FB SZ 3 RT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11323950
• Report Number: 1038671-2021-00037
• Device Sequence Number: 3248128
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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 Model Number: 350-12-03
• Device Catalogue Number: 350-12-03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 71