MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; THREE PEG PATELLA 32MM

Model Number 200-02-32

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, approximately 20 months after the initial patellar implant, this (b)(6) y/o female was revised and exchanged due to left knee patellar mal-tracking.Patient was last known to be in stable condition following the event.Device disposed by hospital and will not return.

Manufacturer Narrative

(h3) the evaluation of the revision may have been the result of an alignment or rotational issue between the patella and femoral component, not allowing the two devices to properly articulate.However, this cannot be confirmed because the component was not returned for evaluation.

• Brand Name: OPTETRAK
• Type of Device: THREE PEG PATELLA 32MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10786892
• MDR Text Key: 214641765
• Report Number: 1038671-2020-00603
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862039590
• UDI-Public: 10885862039590
• Combination Product (y/n): N
• PMA/PMN Number: K932690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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
• Device Operator: No Information
• Device Expiration Date: 01/25/2023
• Device Model Number: 200-02-32
• Device Catalogue Number: 200-02-32
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 12/02/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR