FDA Adverse Event
Injury
Summary report: N
NATURAL-KNEE FLEX PROLONG ARTICULAR SURFACE
MDR report key: 1871074
·
Received October 12, 2010
Report
- Report Number
- 1822565-2010-00869
- Event Type
- Injury
- Date Received
- October 12, 2010
- Date of Event
- September 8, 2010
- Report Date
- September 13, 2010
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
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 A MONTH OR SO BEFORE SHE WAS REVISED FOR A BROKEN INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NATURAL-KNEE FLEX PROLONG ARTICULAR SURFACE | KNEE PROSTHESIS | JWH | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |