FDA Adverse Event
Injury
Summary report: N
UNKNOWN LEFT NECK
MDR report key: 2885020
·
Received December 12, 2012
Report
- Report Number
- 9616680-2012-01343
- Event Type
- Injury
- Date Received
- December 12, 2012
- Date of Event
- August 2, 2011
- Report Date
- November 28, 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
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED, HOWEVER BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT STARTED HAVING PAIN ON THE OUTSIDE MIDDLE PART OF HIS HIP IN MAY. PATIENT STATES THAT HE WAS LIMPING. PATIENT HAS HAD MRI AND BLOOD WORK PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN LEFT NECK | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |