MAUDE Adverse Event Report: ARTHREX, INC UNI GLEND SM; IMPLANT, SHOULDER

Model Number 3100068

Device Problems Break (1069); Component Falling (1105); Mechanical Problem (1384); Device Slipped (1584)

Patient Problem Pain (1994)

Event Date 09/02/2015

Event Type  malfunction  

Event Description

The patient underwent a reverse total shoulder several months ago.Recently she started developing a squeaking sensation in her shoulder along with progressive pain.The patient was taken to the operating room for exploration of the shoulder.The glenosphere was grossly loose and simply fell out.The superior screw of the glenosphere was broken.The entire shoulder prosthesis was removed and had to be replaced.

• Brand Name: UNI GLEND SM
• Type of Device: IMPLANT, SHOULDER
• Manufacturer (Section D): ARTHREX, INC; 1370 creekside blvd.; naples, FL 34108
• MDR Report Key: 5147796
• MDR Text Key: 28235562
• Report Number: 5147796
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2019
• Device Model Number: 3100068
• Device Lot Number: 250146908
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2015
• Device Age: 3 MO
• Date Report to Manufacturer: 09/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 84