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