FDA Adverse Event
Injury
Summary report: N
COONRAD / MORREY PIN / BUSHING REPLACEMENT KIT
MDR report key: 2003669
·
Received February 23, 2011
Report
- Report Number
- 1822565-2011-00393
- Event Type
- Injury
- Date Received
- February 23, 2011
- Date of Event
- January 26, 2011
- Report Date
- January 23, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- JDC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE A FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT APPROXIMATELY A WEEK AFTER IMPLANTATION, THE PIN DISASSEMBLED FOR NO APPARENT REASON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COONRAD / MORREY PIN / BUSHING REPLACEMENT KIT | JDC | ZIMMER, INC. | 60573555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |