FDA Adverse Event
Injury
Summary report: N
NKII SINTERLOCK POROUS FEMORAL COMPONENT
MDR report key: 3221427
·
Received July 5, 2013
Report
- Report Number
- 1822565-2013-01080
- Event Type
- Injury
- Date Received
- July 5, 2013
- Date of Event
- May 17, 2013
- Report Date
- June 6, 2013
- Manufacturer
- ZIMMER INC
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- N
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 PREMATURE BACKWARE AND PREMATURE ABRASION OF POLYETHYLENE IS SHOWN ON THE UNDERSIDE OF THE IMPLANT LEADING TO AN ASEPTIC LOOSENING AND BONE DEFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 308253 | NKII SINTERLOCK POROUS FEMORAL COMPONENT | KNE PROSTHESIS | JWH | ZIMMER INC | 61016058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Required Intervention | NATURAL KNEE II ULTRA CONGRUENT TIBIAL INSERT, CATALOG #627501711, LOT #60939827| NATURAL-KNEE II STEMMED TIBIAL PLATE: CATALOG #630701220, LOT #61056571 |