FDA Adverse Event
Injury
Summary report: N
UNKNOWN LEFT STRYKER HIP
MDR report key: 2850806
·
Received November 21, 2012
Report
- Report Number
- 2249697-2012-02443
- Event Type
- Injury
- Date Received
- November 21, 2012
- Date of Event
- July 1, 2008
- Report Date
- November 2, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 PATIENT 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: PATIENT STATED THAT SHE HAS A LEFT STRYKER HIP AS WELL THAT IS GIVING HER PROBLEMS WITH HIP AND BACK PAIN. LEFT SURGERY TOOK PLACE IN (B)(6) 2008 AT (B)(6) HOSPITAL WITH DR (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN LEFT STRYKER HIP | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |