FDA Adverse Event
Other
Summary report: N
TRIATHLON CR FEM COMP #2 L-CEM
MDR report key: 1810739
·
Received August 16, 2010
Report
- Report Number
- 9610726-2010-00257
- Event Type
- Other
- Date Received
- August 16, 2010
- Date of Event
- August 3, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K040267
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "A LEFT PRIMARY CR FEMORAL COMPONENT WAS CEMENTED ON THE PT RIGHT FEMUR. I RECOGNIZED THE ERROR A FEW MINUTES AFTER IMPLANTATION I INFORMED THE SURGEON AND HE EXTRACTED THE COMPONENT. THE SURGEON ELECTED TO CEMENT A RIGHT PS FEMORAL COMPONENT. THE PT APPEARED TO HAVE A GOOD RESULT. THE EXTRACTION AND REIMPLANTATION TOOK APPROX 15 ADDITIONAL MINUTES. NOTE: A 9MM PS INSERT WAS IMPLANTED WITH THE PS RIGHT FEMUR."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON CR FEM COMP #2 L-CEM | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | SPS9Y |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other |