MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TIBIAL INSERT FB SZ 3 LT 7MM

Model Number	350-21-13
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1.5 years post op the initial left ankle replacement with a custom-made talus replacement, this (b)(6) patient was revised because the total talus component has drifted into valgus.Since the vantage tibial bearing was part of the affected recall, the surgeon will be replacing the tibial bearing.There was no surgical delay/prolongation.Device will be returning, surgeon requested engineering to evaluate the device.Patient was last known to be in stable condition following the event.Of note: the initial left ankle replacement for this patient is due to previous trauma.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
As previously mentioned, the reason for the revision surgery was to correct the positioning of the non-exactech custom talar component.The information provided does not allege any issues with the tibial insert.The tibial insert was not returned for evaluation and images of the device were not provided to conduct a visual review.Exactech is not aware of any other complaint reports involving parts from this tibial insert¿s manufacturing lot of (b)(4).Additionally, this specific tibial insert was packaged for approximately 9 months before being implanted.In august of 2021, exactech discovered that a bag used in the packaging of our polyethylene inserts has been produced outside of quality specifications.The use of these non-conforming bags may enable increased oxygen diffusion to the uhmwpe (ultra-high molecular weight polyethylene) insert, resulting in increased oxidation of the material relative to inserts packaged with the specified additional oxygen barrier layer bags that conform to exactech¿s specifications.For inserts with greater than five years of shelf life, increased oxidation of the inserts can lead to premature polyethylene wear resulting in a revision surgery.However, while it was packaged in a non-conforming vacuum bag, the tibial insert involved in this case was on the shelf for less than 5 years before the date of implantation.Therefore, the event as reported does not appear to be related to the design, manufacturing, or reasonably foreseeable misuse of exactech¿s device.The following sections have corrected information: (h6) component code: 4755, part/component/sub-assembly term not applicable.

• Brand Name: VANTAGE
• Common Device Name: TIBIAL INSERT FB SZ 3 LT 7MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14307956
• Report Number: 1038671-2022-00531
• Device Sequence Number: 5026638
• Product Code: HSN
• UDI-Device Identifier: 10885862276278
• UDI-Public: 10885862276278
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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: 350-21-13
• Device Catalogue Number: 350-21-13
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2020
• 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; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male