FDA Adverse Event
Injury
Summary report: N
UNKNOWN STRYKER LEFT HIP
MDR report key: 2884990
·
Received December 11, 2012
Report
- Report Number
- 2249697-2012-02633
- Event Type
- Injury
- Date Received
- December 11, 2012
- Date of Event
- February 7, 2012
- Report Date
- November 19, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT IS REPORTED THAT: THE PT REPORTS EXPERIENCING EXTREME ABDOMINAL PAIN AND DIFFICULTY URINATING AFTER HIS REVISION SURGERY OF (B)(6) 2012. IT WAS DETERMINED THAT THE HIP IMPLANTS WERE PRESSING ON THE PT'S PROSTATE AND OTHER ORGANS. THE PT HAD GREEN LIGHT LASER SURGERY ON HIS PROSTATE IN (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN STRYKER LEFT HIP | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other |