FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN PRODUCT RIGHT HIP
MDR report key: 1033028
·
Received April 22, 2008
Report
- Report Number
- 2249697-2008-00096
- Event Type
- Malfunction
- Date Received
- April 22, 2008
- Date of Event
- February 11, 2008
- Report Date
- March 24, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 THAT, "PT CALLED AND REPORTED THAT SINCE HER SURGERY, ONE LEG IS LONGER THAN THE OTHER (THE IMPLANT LEG IS ALLEGEDLY 2.54 CENTIMETERS LONGER). THIS IS CAUSING HER PAIN IN HER KNEES AND BACK AND HER SHOE HAD TO BE BUILT UP ONE INCH. DR. TOLD HER THAT HE IMPLANTED "THE SMALLEST HIP HE HAD AVAILABLE". ORIGINAL PAIN STILL PERSISTS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT RIGHT HIP | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other |