FDA Adverse Event
Other
Summary report: N
CERAMTEC CERAMIC INS/SLEEVE TRIDENT E
MDR report key: 1221808
·
Received November 3, 2008
Report
- Report Number
- 9616680-2008-00356
- Event Type
- Other
- Date Received
- November 3, 2008
- Date of Event
- June 15, 2008
- Report Date
- October 28, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- P000013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
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 "PATIENT WAS WALKING WHILE EXERCISING ON A NEW MACHINE. HIP STARTED TO SQUEAK. SQUEAK LASTED ABOUT 1 MONTH UNTIL SATURDAY (B) (6) 2008. WHILE PATIENT WAS TURNING OVER IN BED, SHE HEARD HER HIP POP WHICH MADE THE HIP POP BACK INTO PLACE AND HAS NOT HAD SQUEAKING SINCE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CERAMTEC CERAMIC INS/SLEEVE TRIDENT E | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 10887303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |