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 |