FDA Adverse Event
Injury
Summary report: N
NEXGEN CR ARTICULAR SURFACE AC
MDR report key: 3893660
·
Received June 10, 2014
Report
- Report Number
- 1822565-2014-00725
- Event Type
- Injury
- Date Received
- June 10, 2014
- Report Date
- May 13, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: THE FEMORAL AUGMENT AND FEMORAL COMPONENT ARE INCOMPATIBLE. THE FEMORAL AND ARTICULAR SURFACE COMPONENTS ARE ALSO INCOMPATIBLE. A HEALTH HAZARD EVAL INDICATED THAT THE FEMORAL AND ARTICULAR SURFACE INCOMPATIBILITY MAY RESULT IN SOFT TISSUE IMPINGEMENT, PAIN, ANTERIOR LIFT-OFF OF 17MM OR THICKER ARTICULAR SURFACE, AND REVISION SURGERY. IT IS LIKELY THAT THE REPORTED PAIN IS DUE TO THE IMPLANTATION OF INCOMPATIBLE COMPONENTS. EVAL: DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340306 | NEXGEN CR ARTICULAR SURFACE AC | JWH | ZIMMER, INC. | 61524687 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | CATALOG # 00599003410, LOT # 61579786 -| CATALOG # 00575001401, LOT # 61532453 -| MANUFACTURED BY ZIMMER LTD - (B)(4)| NEXGEN PRECOAT FEMORAL AUGMENT BLOCK QTY 2:| MANUFACTURED BY ZIMMER INC - (B)(4)| NEXGEN CR-FLEX GSF FEMORAL COMPONENT: |