FDA Adverse Event Injury Summary report: N

UNKNOWN RIGHT HIP NECK

MDR report key: 2910424 · Received January 8, 2013

Report

Report Number
9616680-2013-90072
Event Type
Injury
Date Received
January 8, 2013
Date of Event
January 31, 2011
Report Date
December 19, 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
NY, US
Reporter Occupation
NOT APPLICABLE

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. ADD'L 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 EXPERIENCING PAIN IN THE FRONT OF HIS THIGH AND UP INTO THE BUTTOCK AREA. PT STATES THAT HIS HIP PROTRUDES AT THE INCISION SITE. PT STATES HE HAS HAD THE PAIN FOR THE LAST YR. PT HAS HAD CORTISONE INJECTIONS AND PHYSICAL THERAPY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
8684 UNKNOWN RIGHT HIP NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

Patients

Seq Age Sex Outcome Treatment
1 79 YR Other