FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN PRODUCT - RIGHT HIP
MDR report key: 1892800
·
Received November 3, 2010
Report
- Report Number
- 9616680-2010-00703
- Event Type
- Malfunction
- Date Received
- November 3, 2010
- Date of Event
- October 19, 2010
- Report Date
- October 19, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDO
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURED. ADDITIONAL INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "CUSTOMER NOT SURE OF PRODUCT CODES, (B)(6) 2008 WAS HIS IMPLANT DATE. HE HAS BEEN TELLING HIS DOCTOR HE FEELS LIKE IT JOLTS, MOVES AROUND EVER SINCE HE WAS WALKING AFTER THE SURGERY. IT IS SQUEAKING AND PEOPLE CAN HEAR IT. WANTS TO KNOW HOW MUCH WEIGHT HE CAN CARRY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT - RIGHT HIP | IMPLANT | JDO | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |