FDA Adverse Event
Injury
Summary report: N
RIGHT HIP REJUVENATE NECK
MDR report key: 2896157
·
Received December 28, 2012
Report
- Report Number
- 9616680-2012-01514
- Event Type
- Injury
- Date Received
- December 28, 2012
- Date of Event
- February 9, 2011
- Report Date
- December 12, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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 MANUFACTURER. ADDITIONAL INFO WAS REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT IS REPORTED THAT: PT RECEIVED RECALL NOTIFICATION FROM THE SURGEON. PT COMPLAINS OF PAIN, STIFFNESS, TIGHTNESS AND SORENESS IN THE GROIN, THE INCISION SITE DOWN TO THE KNEE SINCE SEPTEMBER 2012. PT REPORTS BLOOD WORK MRI SHOW ALTR WITH ELEVATED COBALT AND CHROMIUM LEVELS, METALLOSIS, PSEUDO TUMOR ON THE HIP. SURGEON RECOMMENDS REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIGHT HIP REJUVENATE NECK | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other |