FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN PRODUCT
MDR report key: 1163451
·
Received September 10, 2008
Report
- Report Number
- 2249697-2008-00261
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- August 13, 2008
- Report Date
- August 13, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. DEVICE IS STILL IMPLANTED IN PATIENT AND THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. NO EVALUATION WILL BE PERFORMED. SHOULD DEVICE BECOME AVAILABLE WITH ADDITIONAL INFORMATION A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THAT, "HE IS EXPERIENCING A LOT OF PAIN IN GROIN AREA. CANNOT PUSH/CARRY ANY HEAVY LOADS. PATIENT HAS A LOT OF TROUBLE WALKING. PATIENT IS CURRENTLY WORKING WITH SURGEON TO HAVE TOTAL HIP REPLACED. PATIENT WANTS TO BE COMPENSATED FOR HIS SURGERY AND LOSS WORK TIME."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Other |