FDA Adverse Event Malfunction Summary report: N

*

MDR report key: 2181712 · Received July 22, 2011

Report

Report Number
2181712
Event Type
Malfunction
Date Received
July 22, 2011
Date of Event
April 25, 2011
Report Date
July 22, 2011
Manufacturer
DEPUY ORTHOPAEDICS, INC.
Product Code
JDI
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

NOTES FROM THE SURGEON'S H&P: "THIS IS A MALE PT WHO HAD A LEFT TOTAL HIP ARTHROPLASTY DONE A COUPLE YEARS BACK. HE STATES THAT RECENTLY HE HAS HAD SEVERE LEFT GROIN PAIN AND THIGH PAIN. HE SAYS THE PAIN IS WORSE WITH WEIGHTBEARING ACTIVITY AND HE GETS SOME IMPROVEMENT WITH REST. HE SAYS THE PAIN IS LOCATED IN HIS GROIN REGION, IS SHARP AND STABBING IN QUALITY. HE STATES THE PAIN IS SEVERE ENOUGH THAT IT IS AFFECTING HIS NORMAL ACTIVITIES OF DAILY LIVING. HE SAYS HE HAS TRIED CONSERVATIVE TREATMENT WITH NO RELIEF OF HIS SYMPTOMS. HE HAD X-RAYS TAKEN, WHICH SHOWS WHAT APPEARS TO BE WELL FIXED PROSTHESIS IN GOOD ALIGNMENT WITH NO SIGNS OF LOOSENING OR FRACTURES. HE DOES HAVE A METAL ON METAL TYPE IMPLANT.PLAN: HE DID HAVE A BONE SCAN DONE, WHICH DID NOT DEMONSTRATE LOOSING. HIS SED RATE AND CRP WERE NORMAL, SO HE WAS RULED OUT FOR INFECTION. THE ONLY OTHER THING THAT COULD BE CAUSING HIS PAIN IS METAL ON METAL REACTION. SINCE HE IS HAVING A SIGNIFICANT AMOUNT OF PAIN IN HIS LEFT HIP AND HE HAS FAILED CONSERVATIVE TREATMENT FOR HIS SYMPTOMS, WE WILL GO AHEAD AND REVISE HIM TO DO A BALL LINER EXCHANGE AND CONVERT HIM TO A POLYETHYLENE LINER WITH A CERAMIC BALL HEAD TO GET RID OF HIS METAL ON METAL IMPLANT." THE PATIENT UNDERWENT LEFT HIP REVISION-BALL AND LINER EXCHANGE. FINDINGS: MILD FRIBROSIS WITHIN SCAR TISSUE. POST-OPERATIVE DIAGNOSIS: METAL-ON-METAL REACTION L HIP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 * BALL AND LINER JDI DEPUY ORTHOPAEDICS, INC. 36 X 54 D 121887354

Patients

Seq Age Sex Outcome Treatment
1 63 YR