FDA Adverse Event
Injury
Summary report: N
UNKNOWN STRYKER RIGHT HIP
MDR report key: 2885189
·
Received December 17, 2012
Report
- Report Number
- 2249697-2012-02694
- Event Type
- Injury
- Date Received
- December 17, 2012
- Date of Event
- September 15, 2010
- Report Date
- November 27, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
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: THE PATIENT STATES THAT SHE DISLOCATED HER RIGHT HIP, WHEN TURNING HER HEAD WHILE SHE WAS SEATED. THE HIP WAS PUT BACK INTO PLACE. ON (B)(6) 2010, THE HIP DISLOCATED AGAIN WHILE SLEEPING. THE PATIENT WAS PLACED IN A HIP BRACE FOR FOUR WEEKS UNTIL THE REVISION SURGERY COULD BE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN STRYKER RIGHT HIP | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |