FDA Adverse Event
Injury
Summary report: N
UNKNOWN PRODUCT
MDR report key: 1060382
·
Received June 12, 2008
Report
- Report Number
- 2249697-2008-00168
- Event Type
- Injury
- Date Received
- June 12, 2008
- Date of Event
- June 20, 2007
- Report Date
- May 6, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE DR THAT, "PT HAD A FRACTURE DISLOCATION OF HIS HIP WITH PINNING, AND IN 2007 HE STARTED HAVING LEFT HIP PAIN AND OF ASEPTIC LOOSENING WAS MADE BASED ON THE X-RAY"
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 | 73 YR | Required Intervention |