FDA Adverse Event Malfunction Summary report: N

ZIMMER TRABECULAR METAL SHOULDER PIN

MDR report key: 2021397 · Received February 8, 2011

Report

Report Number
1822565-2011-00211
Event Type
Malfunction
Date Received
February 8, 2011
Date of Event
January 13, 2011
Report Date
January 13, 2011
Manufacturer
ZIMMER, INC.
Product Code
HTY
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
GM
Reporter Occupation
PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

IT IS REPORTED THAT THE PINS BROKE AT THE TIP OF THE THREAD DURING INSERTION INTO THE GLENOID.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ZIMMER TRABECULAR METAL SHOULDER PIN HTY ZIMMER, INC. 61594738

Patients

Seq Age Sex Outcome Treatment
1 CAT # 47430902500, LOT #61594738| SYSTEM INSTRUMENTATION PIN| ZIMMER TRABECULAR METAL REVERSE SHOULDER