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 05/13/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, a (b)(6) female was found to have a mispositioning of the right patella implant, the 32mm patella implant was removed and a new 29mm implant inserted and repositioned.Patient was last known to be in stable condition following the event.Devices were disposed of by the hospital.

Manufacturer Narrative

The evaluation noted that the revision reported 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.(d11) concomitant devices: (cn: (b)(4), sn: (b)(6) - cocr fem head 32mm +0 offset 12/14.(cn: (b)(4), sn: (b)(6) integrip cc, cluster 50mm, g1.

• 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: 10123043
• MDR Text Key: 194127521
• Report Number: 1038671-2020-00295
• 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: 06/08/2020

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: Health Professional
• Device Expiration Date: 05/08/2023
• Device Model Number: 200-02-32
• Device Catalogue Number: 200-02-32
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 06/02/2020
• Supplement Dates FDA Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR