FDA Adverse Event Injury Summary report: N

ASR XL

MDR report key: 1951164 · Received December 16, 2010

Report

Report Number
1951164
Event Type
Injury
Date Received
December 16, 2010
Date of Event
December 7, 2010
Report Date
December 16, 2010
Manufacturer
DEPUY ORTHOPAEDICS, INC.
Product Code
KWA
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
VA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PATIENT UNDERWENT LEFT TOTAL HIP REPLACEMENT A YEAR AND A HALF AGO USING THE DEPUY ASR CUP THAT WAS RECENTLY RECALLED. SHE HAS SLIGHTLY ELEVATED CHROMIUM LEVELS AND HAS WHAT APPEARS TO BE A LOOSE ACETABULAR COMPONENT. THE PT UNDERWENT SURGERY IN LATE FALL OF 2010 FOR THE PURPOSE OF UNDERGOING A REVISION OF THE ACETABULAR COMPONENT. PER THE OPERATIVE REPORT: "THE FASCIAL LEVEL WAS INCISED AND THE GLUTEAL MUSCULATURE DID NOT LOOK TERRIBLY ABNORMAL. IT WAS A LITTLE BIT PALE ON ITS MORE INFERIOR EDGE. IT WAS RETRACTED PROXIMALLY AND DENSE FIBROUS TISSUE WAS NOTED UNDERNEATH OF IT, CONSISTING OF A SLIGHT BULGE WERE FLUID COULD BE PALPATED. A SHARP INCISION INTO THE FIBROUS TISSUE BULGE WAS MADE AND CLEAR FLUID CAME OUT OF IT, WHICH WAS SENT FOR CULTURE AND SENSITIVITY (AEROBICALLY AND ANAEROBICALLY). A LARGE AMOUNT OF TIME WAS TAKEN TO RESECT THE PSEUDOCAPSULE THAT WAS AROUND THE HIP JOINT. IT WAS VERY DENSELY FIBROUS AND WHITE IN COLOR. THE HIP CAME INTO VIEW. THERE WAS A SMALL AMOUNT OF BLACK NECROTIC DEBRIS AT THE INTERFACE BETWEEN THE HEAD AND THE NECK. THE HIP WAS DISLOCATED POSTERIORLY AND AGAIN SOME NECROTIC TISSUE WAS SEEN UNDERNEATH THE SLEEVE OF THE 50 MM HEAD. THE HEAD WAS EASILY TAKEN OFF OF THE NECK. THE RETRACTORS WERE THEN PLACED AROUND THE ACETABULUM. DUE CARE WAS MADE TO AVOID ANY DAMAGE TO THE SCIATIC NERVE. THE NERVE WAS IDENTIFIED BY PALPATION AND WAS PROTECTED THROUGHOUT THE CASE. AFTER WE HAD DISLOCATED THE HIP POSTERIORLY AND TAKEN THE HEAD OFF, THE ACETABULAR COMPONENT WAS FOUND TO BE EXTREMELY LOOSE AND WAS MADE MOBILE BY PUSHING A FINGER AGAINST IT. IT WAS EASILY TAKEN OUT WITH NO INSTRUMENTATION REQUIRED, AS WAS GRABBED AND PULLED OUT. THERE WAS SOME FIBROUS TISSUE AND HARD BONE UNDERNEATH THIS. THERE WAS ALREADY SOME PENETRATION THROUGH THE MEDIAL WALL, BUT IT LOOKED LIKE IT WAS ONLY MAYBE 1.5 CM OF DIAMETER OF PENETRATION."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ASR XL PROSTHESIS, HIP, METAL ON METAL KWA DEPUY ORTHOPAEDICS, INC. * 2937010

Patients

Seq Age Sex Outcome Treatment
1 58 YR Hospitalization| R NO OTHER THERAPIES