FDA Adverse Event
Injury
Summary report: N
ZIMMER REVERSE SHOULDER LINER
MDR report key: 3201993
·
Received June 26, 2013
Report
- Report Number
- 1822565-2013-01025
- Event Type
- Injury
- Date Received
- June 26, 2013
- Date of Event
- April 23, 2013
- Report Date
- May 29, 2013
- Manufacturer
- ZIMMER INC
- Product Code
- KWT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- 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 PT FELL OFF THE COUCH, DISLOCATING HIS SHOULDER. UNDER FURTHER EXAM AND WHILE TRYING TO REDUCE THE SHOULDER THE DOCTOR REALIZED THE POLY IMPLANT HAD DISASSOCIATED FROM THE STEM. THE PT WAS REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 289705 | ZIMMER REVERSE SHOULDER LINER | SHOULDER PROSTHESIS | KWT | ZIMMER INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention | ZIMMER REVERSE SHOULDER STEM, CATALOG#UNK| LOT #UNK |