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