FDA Adverse Event Malfunction Summary report: N

REVELATION

MDR report key: 3139462 · Received May 17, 2013

Report

Report Number
3139462
Event Type
Malfunction
Date Received
May 17, 2013
Date of Event
April 15, 2013
Report Date
May 17, 2013
Manufacturer
DJO GLOBAL
Product Code
LPH
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

THE PATIENT UNDERWENT AN UNCOMPLICATED LEFT HIP REVISION SEVERAL YEARS AGO. THE PATIENT HAD DONE EXTREMELY WELL WITH NO PROBLEMS UNTIL A COUPLE OF MONTHS AGO WHEN HE STARTED TO DEVELOP SOME VERY SLIGHT HIP DISCOMFORT LATERALLY. RECENTLY DEVELOPED CREPITUS IN THE JOINT; THE PATIENT WAS COMPLAINING OF A SQUEAKING-LIKE SENSATION IN THE LEFT HIP WITH STARTUP AND WALKING. THE PATIENT WAS ADMITTED FOR REVISION. NOTES FROM THE OPERATIVE REPORT:"INCISION WAS CARRIED DOWN THROUGH SUBCUTANEOUS TISSUE THROUGH A MODERATE AMOUNT OF SCAR TISSUE DOWN TO THE ILIOTIBIAL BAND. A SIGNIFICANT AMOUNT OF SCAR WAS ENCOUNTERED, BUT UPON RELEASING THE ILIOTIBIAL BAND, THE BLACKENED BURSA WAS ENCOUNTERED. THROUGH VERY CAREFUL METICULOUS DISSECTION, THE BURSAL SAC WAS SEPARATED FROM THE ILIOTIBIAL BAND ANTERIORLY AND POSTERIORLY ALLOWING FOR THE FLAPS TO BE SEPARATED MORE DEFINITIVELY. THEN, STARTING POSTERIORLY THE BURSAL SAC WAS FREED UP OFF THE POSTERIOR CAPSULE CARRIED DISTALLY AND THEN ANTERIORLY AND THEN PROXIMALLY. THE BURSAL SAC WAS EMANATING FROM THE ANTERIOR ASPECT OF THE HIP JOINT WHERE PROTRUDED THROUGH THE GLUTEUS MEDIUS AND MINIMUS, WHICH WHERE THERE WAS A SIGNIFICANT AMOUNT OF DEGENERATION OF THE ENTIRE MUSCLE. THERE WAS A LARGE HOLE. THIS WAS THEN EXCISED CAREFULLY DOWN INTO THE JOINT. ONCE TAKEN OUT OF THE JOINT, IT WAS NOTED THAT THE POLYETHYLENE WAS COMPLETELY DISSOCIATED FROM THE ACETABULAR LINER. THIS ACCOUNTED FOR THE ABNORMAL X-RAYS. THE HIP WAS THEN DISLOCATED. THE HEAD WAS DISIMPACTED. IT SHOWED A LARGE SWATH OF BURNISHING BLACK TISSUE. AT THIS POINT, THROUGH VERY CAREFUL METICULOUS DISSECTION, THE BLACKENED TISSUE WAS DEBRIDED AROUND THE RIM OF THE ACETABULUM. THE POLYETHYLENE LINER WITH THE METAL LINER WAS REMOVED. THE RIM WAS ALL DEGENERATED AND FRAYED. THE METAL LINER PORTION WAS LOOSE WITHIN THE POLYETHYLENE LINER. AFTER THE BLACKENED TISSUE WAS REMOVED CIRCUMFERENTIALLY FROM THE ACETABULUM AS WELL AS THE FEMUR, FEMUR WAS TESTED AND IT WAS CONFIRMED TO BE STABLE. THERE WAS NO EVIDENCE OF ANY LOOSENING. ACETABULUM WAS IMPACTED IN A CIRCUMFERENTIAL MANNER AND WAS STABLE AS WELL." THE HIP REVISION WAS CARRIED OUT, AND THE PATIENT TOLERATED IT WELL WITH NO COMPLICATIONS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LEFT TOTAL HIP REVISION - REMOVAL OF DISSOCIATED POLYETHYLENE LINER WITH INSERTION OF NEW HXL FMP POLYETHYLENE LINER.REMOVAL OF COBALT CHROME HEAD AND INSERTION OF 36 MM CERAMIC HEAD WITH -3.5 COBALT CHROME METAL SLEEVE FOR THE NECK.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
220359 REVELATION PROSTHESIS, HIP LPH DJO GLOBAL * *

Patients

Seq Age Sex Outcome Treatment
1 71 YR