FDA Adverse Event
Other
Summary report: N
C-TAPER COCR LFIT HEAD 28MM/0
MDR report key: 1295799
·
Received January 20, 2009
Report
- Report Number
- 2249697-2009-00029
- Event Type
- Other
- Date Received
- January 20, 2009
- Date of Event
- December 17, 2009
- Report Date
- December 17, 2009
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K910988
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT, "DURING THE SURGERY, THERE WAS NO MORSE TAPER HEAD IN THE OPERATING ROOM THEREFORE, THE SURGEON IMPLANTED THE C TAPER HEAD ON THE MORSE TAPER NECK USING BONE CEMENT." THIS IS NOT A REPORT OF DEVICE MALFUNCTION, BUT OFF-LABEL USE WHICH COULD CARRY ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-TAPER COCR LFIT HEAD 28MM/0 | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Other |