MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE SHOULDER SYSTEM; TOTAL SHOULDER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 08/07/2013

Event Type  Other  

Event Description

Revision of equinoxe shoulder components due to loss of function.Event was discovered through exactech clinical research.The surgeon did not consider this event to be device related.

Manufacturer Narrative

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

• Brand Name: EQUINOXE SHOULDER SYSTEM
• Type of Device: TOTAL SHOULDER
• Manufacturer (Section D): EXACTECH, INC.; 2320 n.w. 66th ct.; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 n.w. 66th ct.; gainesville, FL 32653 ; 8003922832
• MDR Report Key: 3608246
• MDR Text Key: 4171778
• Report Number: 1038671-2014-00006
• Device Sequence Number: 1
• Product Code: KWT
• 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
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2014
• 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