FDA Adverse Event Injury Summary report: N

LFIT ANATOMIC FEMORAL HEAD

MDR report key: 3944698 · Received July 14, 2014

Report

Report Number
MW5037298
Event Type
Injury
Date Received
July 14, 2014
Date of Event
February 15, 2011
Report Date
July 13, 2014
Manufacturer
STRYKER
Product Code
JDI
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
IA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD A HIP REVISION SURGERY ON (B)(6) 2011. I KNEW SOMETHING WAS WRONG IMMEDIATELY AS THE PAIN KEPT GETTING WORSE IN MY HIP AND I WAS LIMPING, REQUIRING ME TO USE A CANE. I KEPT GOING IN TO SEE THE SURGEON WHO DID MY SURGERY. I NOW KNOW THAT HE IS SPINAL SPECIALIST AND NOT A HIP SPECIALISTS AND I AM TRYING TO FIGURE OUT IF HE WAS REALLY QUALIFIED TO HAVE DONE MY SURGERY. I LAST SAW HIM ON (B)(6) 2012 AND HE PRESCRIBED VOLTAREN GEL TO APPLY TO AFFECTED AREA ON HIP AND AGAIN ORDERED PHYSICAL THERAPY, WHICH I HAD DONE FAITHFULLY AT HOME BUT, ONLY THE ULTRA-SOUND REALLY MADE HIP FEEL BETTER. I WENT TO ANOTHER ORTHO OFFICE AND THEY SAID THE SAME THING, BURSITIS. ON (B)(6) 2013, I HAD BACK SURGERY FOR SEVERE SPINAL STENOSIS AND BONE SPUR REMOVAL HOPING THAT WOULD RELIEVE THE PAIN. IT RELIEVED THE SHOOTING PAIN TO TOES, BUT NOT THE HIP PAIN. ON (B)(6) 2013, MY HIP DISLOCATED FOR THE 1ST TIME. I WAS KEPT IN THE HOSP FOR SEVERAL DAYS AND PUT IN A HIP ABDUCTOR BRACE. XRAY'S SHOWED THAT PELVIS WAS BROKEN BUT, WE WERE NEVER INFORMED OF THIS UNTIL RECENTLY WHEN AN EXPERT WITNESS FOR LAWYER INFORMED US THIS PAST (B)(6). HIP DISLOCATED 2ND TIME ON (B)(6) 2013. I TOLD SURGEON THAT HE JUST HAD TO FIX MY HIP. I CAN'T STAND ANYMORE PAIN. DR TOLD ME TO COME BACK IN 3 WEEKS AND DISCUSS WHAT TO DO NEXT BUT, I HAD HAD ENOUGH SO I DROVE MYSELF TO (B)(6) TO SEE WHAT THEY WOULD HAVE TO SAY. SAW (B)(6) ORTHO DR ON (B)(6) 2013 AND HE COULD TELL JUST BY LOOKING AT OLD X-RAYS THAT I HAD A MAJOR PROBLEM. HAD BLOOD TESTS, HIP MRI, HIP XRAYS, AND HIP ASPIRATION, VERY PAINFUL. SAW (B)(6) DR ON (B)(6) 2013 AND HE SAID THAT I HAD A MAJOR PSEUDOTUMOR AND MY COBALT BLOOD LEVELS WERE 6.5. NOT AS HIGH AS THEY HAD SEEN AND HE SAID THAT THE PELVIS NEEDED REINFORCEMENT; ALSO, THE OUTER THIGH BONE WOULD NEED BONE GRAFTING AS THE COBALT HAD EATEN MY BONE AND MUSCLES. I HAD SURGERY ON (B)(6) 2013. I HAD THE BIGGEST PSEUDOTUMOR THAT (B)(6) HAD EVER SEEN AND MY BONE HAS SEVERE NECROSIS AND MORE MUSCLE WAS AFFECTED THEN THEY HAD HOPED. I DISLOCATED FOR THE 3RD TIME, (B)(6) 2014. NOW PLATE WAS BROKEN THAT WAS PUT IN TO REINFORCE THE PELVIS. WENT BACK TO (B)(6) FOR CHECKUP (B)(6) 2014 BONE IS NOT HEALING IN PELVIS OR OUTER THIGH BONE. BACK TO (B)(6), (B)(6) FOR ANOTHER RECHECK BUT JUST NOT HEALING. BACK TO (B)(6) ON (B)(6) 2014, BONE JUST NOT GROWING, NECROSIS. HAD TALKED AT AN EARLIER APPOINTMENT ABOUT MUSCLE TRANSFER BUT DR CHECKED INTO THIS FOR ME AND IT WAS NOT REALLY AN OPTION AS I WOULD ONLY GET A 1 DEGREE IMPROVEMENT. THAT WAS DISAPPOINTING. DISLOCATED FOR THE 4TH TIME, (B)(6) 2014. CALLED (B)(6) BACK AND THEY SAID THAT I REALLY DID NOT HAVE ANY OPTIONS LEFT NOW BUT TO PUT IN A BIGGER CUP IN HIP TOP AND A RESTRICTOR HEAD PUT IN. I HAD SURGERY AT (B)(6) ON (B)(6) 2014 TO DO THIS SINCE I REALLY DON'T HAVE ANY OTHER OPTIONS LEFT AND WOULD LIKE TO GET SOME PAIN RELIEF AND MAY GET BACK TO MY JOB. THAT IS NOT REALLY A REALITY. I AM BEGINNING TO BELIEVE. I AM (B)(6) AS OF (B)(6) 2014. I REALLY NEED TO KNOW WHEN ORTHO DR'S WERE INFORMED OF THE TERRIBLE TROUBLE WITH METAL ON METAL HIPS. I HAD CONTINUALLY ASKED THAT QUESTION EVERY TIME I WENT IN FROM (B)(6) 2011 TO (B)(6) 2013. DR TOLD ME THAT I DIDN'T HAVE ANY OF THE RECALLED HIPS AND THAT THERE WAS NOTHING WRONG WITH ME AND THAT HE WAS SEEING ME TOO OFTEN AS HE SEES HIS OTHER PTS EVERY 2 YEARS, BUT I SAID YOU ARE THE SURGEON WHO DID THE SURGERY WHO I WAS TO GO TO. HE PROCEEDED TO TELL THAT I COULD THEN GET A 2ND OPINION FROM ONE OF HIS PARTNERS. WELL I WAS TOO UPSET BY THEN AND LEFT HIS OFFICE. NOW AFTER (B)(6) HAS A VIDEO OF MY SURGERY AND I HAVE PHOTOS OF SURGERY I AM LOOKING FOR DEEP ANSWERS AS TO WHY OR WHEN DR'S WERE REALLY NOTIFIED ABOUT THE METAL-ON-METAL-HIPS AND HOW PTS SHOULD HAVE BEEN TREATED. DR NEVER ONCE SUGGESTED A BLOOD TEST TO SEE IF COBALT ALLERGY WAS A PROBLEM. I AM IN DESPERATE NEED OF INFO AND HAVE FILLED COURT PAPERS. HELP ME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
409945 LFIT ANATOMIC FEMORAL HEAD LFIT ANATOMIC FEMORAL HEAD JDI STRYKER 8260-9-136 MJRE20

Patients

Seq Age Sex Outcome Treatment
1 54 YR Hospitalization| O| R| S