FDA Adverse Event Injury Summary report: N

UNKNOWN STRYKER RIGHT HIP

MDR report key: 2910686 · Received January 8, 2013

Report

Report Number
2249697-2013-90055
Event Type
Injury
Date Received
January 8, 2013
Date of Event
November 10, 2004
Report Date
December 14, 2012
Manufacturer
STRYKER ORTHOPAEDICS MAHWAH
Product Code
JDI
PMA / PMN Number
UNK
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
IN, US
Reporter Occupation
NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

IT IS REPORTED THAT: PATIENT HAS HAD A DULL ACHE IN HIS HIP FOR THE PAST FEW MONTHS. PATIENT'S HIP BEGAN POPPING WITH EACH STEP A FEW WEEKS AGO. PATIENT HAS PAIN DAILY AND THE INTENSITY IS INCREASING. PATIENT IS SCHEDULING AN APPOINTMENT WITH A NEW ORTHOPAEDIST SOON.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
9934 UNKNOWN STRYKER RIGHT HIP IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

Patients

Seq Age Sex Outcome Treatment
1 36 YR Other