FDA Adverse Event
Malfunction
Summary report: N
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTION PIN
MDR report key: 6108850
·
Received November 17, 2016
Report
- Report Number
- 6108850
- Event Type
- Malfunction
- Date Received
- November 17, 2016
- Date of Event
- October 25, 2016
- Report Date
- November 15, 2016
- Manufacturer
- ZIMMER TRABECULAR METAL TECHNOLOGY, INC.
- Product Code
- KWT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING TOEL SHOULDER, REVERSE, RIGHT END OF PIN BROKE. SURGEON LEFT IN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 761123 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTION PIN | PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER | KWT | ZIMMER TRABECULAR METAL TECHNOLOGY, INC. | 2.5 MM | 63339268 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |