FDA Adverse Event
Injury
Summary report: N
LEFT HIP NECK
MDR report key: 2885255
·
Received December 18, 2012
Report
- Report Number
- 9616680-2012-01432
- Event Type
- Injury
- Date Received
- December 18, 2012
- Date of Event
- July 1, 2011
- Report Date
- November 29, 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
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT 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: PATIENT IS EXPERIENCING PAIN IN HIS LEFT HIP. PATIENT ALSO STATES THAT HE IS HAVING PAIN IN THE JOINT AREA AND THAT IT SHOOTS DOWN HIS LEG. PATIENT STATES THAT THE PAIN STARTED SIX TO EIGHT MONTHS AFTER SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEFT HIP NECK | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other |