MAUDE Adverse Event Report: EXACTECH, INC OPTETRAK TIBIAL INSERT, POSTERIOR STABILIZED

Catalog Number 204-22-15

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 12/10/2013

Event Type  Injury  

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.

Event Description

Revision due to tibial insert wear.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of tibial insert wear, possibly related to excessive posterior slope of the tibial insert and/or axial rotation mismatch of the femoral component relative to the insert.However, this cannot be confirmed because neither the device nor x-rays were provided for evaluation.

Event Description

Revision due to tibial insert wear.

• Brand Name: OPTETRAK TIBIAL INSERT, POSTERIOR STABILIZED
• Type of Device: TIBIAL INSERT
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 6063273
• MDR Text Key: 58652500
• Report Number: 1038671-2016-00700
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 204-22-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention