FDA Adverse Event
Injury
Summary report: N
NEXGEN LCCK FEMORAL COMPONENT
MDR report key: 3934580
·
Received June 26, 2014
Report
- Report Number
- 1822565-2014-00785
- Event Type
- Injury
- Date Received
- June 26, 2014
- Date of Event
- September 15, 2011
- Report Date
- May 30, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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 WAS REVISED DUE TO LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 372948 | NEXGEN LCCK FEMORAL COMPONENT | JWH | ZIMMER, INC. | 60729629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | LOT#60918433,| CAT#00599003420, LOT#70057400,| NEXGEN STEMMED TIBIAL COMPONENT, CAT#00598003701,| SURGICAL PRODUCTS| DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC| PALACOS BONE CEMENT, CAT#UNK, LOT#UNK,| THIS BONE CEMENT IS MFG AT HERAEUS MEDICAL AND| NEXGEN TIBIAL BLOCK,CAT#00598800327, LOT#60372795,| CAT#00599003401, LOT#60741683,| NEXGEN STEM EXTENSION,CAT#00598801014, LOT#604924,| NEXGEN STEMMED EXTENSION, CAT#00598801010,| NEXGEN PST FEMORAL AUGEMENT BLOCK,| NEXGEN DISTAL FEMORAL AUGMENT BLOCK,| MFG AT ZIMMER (B)(4), |