FDA Adverse Event
Injury
Summary report: N
UNKNOWN PRODUCT- LEFT STRYKER HIP
MDR report key: 2021312
·
Received March 8, 2011
Report
- Report Number
- 2249697-2011-00270
- Event Type
- Injury
- Date Received
- March 8, 2011
- Date of Event
- February 11, 2006
- Report Date
- February 11, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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 THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT "PT'S HUSBAND CALLED STRYKER BECAUSE HIS WIFE IS EXPERIENCING IMMENSE PAIN IN HER HIP. CAN NOT STAND OR WALK FOR VERY LONG, AND HER ACTIVITY LEVEL HAS BECOME VERY SEDENTARY BECAUSE OF THE PAIN. DR'S HAVE NOT BEEN ABLE TO FIND ANYTHING WRONG THAT IS CAUSING THE PAIN. HAS HAD CT SCAN, BONE SCANS, HAS BEEN GIVEN PAIN MEDICATIONS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT- LEFT STRYKER HIP | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other| R |