FDA Adverse Event
Injury
Summary report: N
NATURAL-KNEE II SYSTEM POROUS STEMMED TIBIAL BASEPLATE
MDR report key: 1292866
·
Received January 16, 2009
Report
- Report Number
- 1822565-2009-00056
- Event Type
- Injury
- Date Received
- January 16, 2009
- Report Date
- January 8, 2009
- Manufacturer
- ZIMMER, INC.
- Product Code
- HSH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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 WAS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2000. REVISION DATE IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NATURAL-KNEE II SYSTEM POROUS STEMMED TIBIAL BASEPLATE | KNEE PROTHESIS | HSH | ZIMMER, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R | INSERT| LOT # UNK| NATURAL-KNEE II SYSTEM ULTRA CONGRUENT TIBIAL| CANCELLOUS BONE SCREW |