FDA Adverse Event
Injury
Summary report: N
DURACON CRUC NON BEAD B/P S2
MDR report key: 2171351
·
Received July 18, 2011
Report
- Report Number
- 9610726-2011-00254
- Event Type
- Injury
- Date Received
- July 18, 2011
- Date of Event
- December 1, 2010
- Report Date
- June 29, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K915512
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "S2 BASEPLATE DURACON CRUCIFORM BROKE MEDIAL SIDE (B)(6) 2010. REPLACED (B)(6) 2011 WITH UNIVERSAL BASEPLATE AND STEM. ORIGINAL DONE 9 YEARS AGO AT (B)(6) HOSPITAL IN (B)(6)."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURACON CRUC NON BEAD B/P S2 | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | LOPO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |