MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; PATELLA

Device Problems Material Too Rigid or Stiff (1544); Appropriate Term/Code Not Available (3191)

Patient Problems Loss of Range of Motion (2032); No Code Available (3191)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2018.Revision due to stiffness with limited range of motion.

Manufacturer Narrative

The engineering evaluation noted that the revision reported was likely the result of insufficient resection of the native patella which led to soft tissue build up and decreased range of motion.However, this cannot be confirmed as the devices were not available for evaluation and no further details were provided.

Event Description

Index surgery: (b)(6) 2018.Revision due to stiffness with limited range of motion.

• Brand Name: OPTETRAK
• Type of Device: PATELLA
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 7859896
• MDR Text Key: 119682607
• Report Number: 1038671-2018-00742
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2018
• 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
• Patient Age: 69 YR