FDA Adverse Event
Malfunction
Summary report: N
MRS 13MM X 127MM FEMORAL STEM
MDR report key: 2903893
·
Received December 4, 2012
Report
- Report Number
- 9610726-2012-00374
- Event Type
- Malfunction
- Date Received
- December 4, 2012
- Date of Event
- November 15, 2012
- Report Date
- November 9, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- KRO
- PMA / PMN Number
- K952970
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 THE PACKAGING ON THE LOANER IMPLANT WAS COMPROMISED. AS THE CIRCULATING NURSE ATTEMPTED TO PLACE THE IMPLANT ON THE STERILE FIELD THE IMPLANT FELL OUT OF THE PACKAGING ONTO THE FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MRS 13MM X 127MM FEMORAL STEM | IMPLANT | KRO | STRYKER ORTHOPAEDICS LIMERICK | NA | TEC1160A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |