FDA Adverse Event Injury Summary report: N

UNKNOWN LEFT HIP NECK

MDR report key: 2893481 · Received December 21, 2012

Report

Report Number
9616680-2012-01485
Event Type
Injury
Date Received
December 21, 2012
Date of Event
June 1, 2010
Report Date
December 3, 2012
Manufacturer
STRYKER ORTHOPAEDICS CORK
Product Code
JDI
PMA / PMN Number
UNK
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MN, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PT IS CURRENTLY EXPERIENCING PAIN. THE PT HAD WENT TO SEE HER SURGEON AND HAD TESTS DONE. THE SURGEON STATES THAT PT NEEDS REVISION SURGERY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 UNKNOWN LEFT HIP NECK IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA UNK

Patients

Seq Age Sex Outcome Treatment
1 68 YR Other| R