MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TIBIAL INSERT FB SZ 2 LT 6MM

Catalog Number	350-21-02
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device: 350-10-03, size 3 locking clip.
Event or Problem Description
Poly swap and gutter debridement.Bony overgrowth limited rom.
Additional Manufacturer Narrative
Section h10: (e3) occupation: physician (g5) pma/510(k)number: k152217 (h3) it was reported that a 58 year old, weight is 257 lbs patient received a poly swap and gutter debridement.Bony overgrowth limited rom sometime in the middle of may 2019.It was also reported that the devices will not be returned but the poly and implant did not have significant wear.This device was used for treatment, not diagnosis.Upon review, there is no indication of manufacturing or design issues.The most likely cause of the reported event may have been the result of bony overgrowth causing limited range of motion, patient conditions, or a combination of the two, which led to limited range of motion, however: this cannot be confirmed because the revised components were not returned to exactech for evaluation.No information provided in the following section(s): a3, a5, b6, b7, d7, g8, h4, h6, h7 section h11: corrections made in the following section(s): (section f) please disregard f6 and f8.These were entered in error.(g4) initial awareness date in initial submission should have been 17-may-2019.

• Brand Name: VANTAGE
• Common Device Name: TIBIAL INSERT FB SZ 2 LT 6MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8662927
• Report Number: 1038671-2019-00321
• Device Sequence Number: 16206761
• Product Code: HSN
• UDI-Device Identifier: 10885862276223
• UDI-Public: 10885862276223
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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: 350-21-02
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/21/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 117