MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER ULNAR COMPONENT; SHOULDER PROSTHESIS

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 04/18/2014

Event Type  Injury  

Event Description

It is reported that the patient was revised due to ulnar loosening.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: UNKNOWN ZIMMER ULNAR COMPONENT
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 3865576
• MDR Text Key: 4566390
• Report Number: 1822565-2014-00667
• 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: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 05/28/2014
• 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