FDA Adverse Event
Injury
Summary report: N
UNKNOWN LEFT HIP
MDR report key: 2831148
·
Received November 2, 2012
Report
- Report Number
- 2249697-2012-02201
- Event Type
- Injury
- Date Received
- November 2, 2012
- Date of Event
- April 29, 2010
- Report Date
- October 11, 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
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. DEVICE INFO HAS NOT BEEN PROVIDED AT THIS TIME. INFO RECEIVED FROM THE PT INDICATED THAT REPORTED DEVICE MAY BE EITHER REJUVENATE OR ABGII. ADD¿L INFO PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADD¿L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT: PT COMPLAINED OF PAIN, KNOT ON HER SCAR, AND ITCHES. ALSO FEELS LIKE NOTHING IS THERE AND HAS A LIMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN LEFT HIP | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other |