FDA Adverse Event
Injury
Summary report: N
COONRAD/MORREY TOTAL ELBOW REPLACEMENT SET BUSHINGS & PINS
MDR report key: 318316
·
Received March 1, 2001
Report
- Report Number
- 1822565-2001-00020
- Event Type
- Injury
- Date Received
- March 1, 2001
- Date of Event
- January 22, 2001
- Report Date
- February 1, 2001
- Manufacturer
- ZIMMER, INC.
- Product Code
- JDC
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
LESS THAN ONE YEAR POST OP, X RAYS REVEALED THE LOCKING PIN HAD DISASSEMBLED, REQUIRING REMOVAL.
Description of Event or Problem · 1
LESS THAN ONE YEAR POST OP, X RAYS REVEALED THE LOCKING PIN HAD DISASSEMBLED, REQUIRING REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8867 | COONRAD/MORREY TOTAL ELBOW REPLACEMENT SET BUSHINGS & PINS | ELBOW PROSTHESIS | JDC | ZIMMER, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |