FDA Adverse Event Injury Summary report: N

HEMICAP PATELLA FEMORAL IMPLANT SYSTEM

MDR report key: 10189580 · Received June 23, 2020

Report

Report Number
MW5095188
Event Type
Injury
Date Received
June 23, 2020
Date of Event
July 10, 2014
Report Date
June 21, 2020
Manufacturer
ARTHROSURFACE, INC.
Product Code
JWH
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I RECEIVED A PARTIAL KNEE REPLACEMENT. THE SURGERY WAS PERFORMED USING A ARTHROSURFACE PF HEMICAP®. THERE WAS NO RECOVERY. FROM DAY ONE AFTER SURGERY, THE PAIN INCREASED AND MY KNEE DETERIORATED TO THE POINT THAT IT WAS DEBILITATING. THE ORTHOPEDIC SURGEON ALONG WITH HIS PAS DIAGNOSED ME WITH SCIATICA, TENDINITIS, REFLEX SYMPATHETIC DYSTROPHY SYNDROME AND OTHER DISORDERS. I ENDURED VERY PAINFUL PHYSICAL THERAPY, THREE SYMPATHETIC NERVE BLOCKS, INJECTIONS, IONTOPHORESIS THERAPY, ETC. ALL WITH NO PAIN RELIEF AND NO IMPROVEMENT OF THE KNEE. MY KNEE WAS SWELLING AND FILLING WITH FLUID WHICH LED TO HAVING THE FLUID DRAINED THEN INJECTING CORTISONE AND PAIN MEDICATIONS ION NUMEROUS OCCASIONS. THE SURGEON REFERRED ME TO ONE OF HIS ASSOCIATES WHO DIAGNOSED ME WITH INFRAPATELLAR CONTRACTURE SYNDROME. HE EXPLAINED THE SERIOUSNESS OF THIS SYNDROME AND I ACTUALLY THOUGHT I WAS GOING TO LOSE MY LEG. HE PERFORMED A RIGHT KNEE ARTHROSCOPIC ABRASION ARTHROPLASTY. HE WAS ALSO TO PERFORM A TIBIAL TUBERCLEPLASTY BUT DID NOT DUE TO SIGNIFICANT DEGENERATIVE CHANGES TO THE MEDIAL COMPARTMENT. DURING A POST-OPERATIVE VISIT, THE ASSOCIATE ADVISED I WOULD NEED A TOTAL KNEE REPLACEMENT IN 9-12 MONTHS. IN THE MEANTIME, I WAS TO WORK TO STRENGTHENING THE LEG OR I WOULD NOT BE ABLE TO RECOVER FROM THE TOTAL KNEE. THE KNEE CONTINUED TO DETERIORATE DAILY AND THERE WAS NO WAY I WOULD BE ABLE TO STRENGTHEN THE LEG IN PREPARATION FOR THE TOTAL KNEE. WE BEGAN REACHING OUT TO ORGANIZATIONS ASSOCIATED WITH INFRAPATELLAR CONTRACTURE SYNDROME (IPC). PATELLOFEMORAL FOUNDATION PROVIDED TWO SPECIALIST WHO WERE WELL VERSED IN IPC. WE PROVIDED BOTH SPECIALIST WITH A FULL COPY OF ALL MEDICAL RECORDS SINCE THE PARTIAL KNEE SURGERY. ONE OF THE SPECIALIST CONTACTED US AND ADVISED I DID NOT HAVE ICP. HE GAVE SPECIFIC REQUIREMENTS OF THE TYPE OF ORTHOPEDIC SURGEON I NEEDED TO SEE. WE PUT TOGETHER PACKETS OF MEDICAL RECORD AND FILMS; AND MAILED THEM TO SEVERAL ORTHOPEDIC SPECIALIST. ONE OF THE DOCTORS CALLED AND ADVISE WE NEEDED TO GO BACK TO THE DOCTOR WHO PERFORMED THE PARTIAL. WE NEEDED TO TELL HIM THAT HE LEFT THE BUTTON OFF THE BACK DURING SURGERY. WITH LACK OF FAITH IN THE ORIGINAL SURGEON, I SAW ANOTHER SPECIALIST WHO THEN EXPLAINED IT WAS THE TROCHLEA GROOVE PLATE THAT WAS NOT USED DURING THE PARTIAL REPLACEMENT. THIS RESULTED IN THE DESTRUCTION OF THE FEMORAL HEAD AS THE PLATE WAS NOT PRESENT TO WORK TOGETHER WITH THE PATELLA IMPLANT (PLASTIC IMPLANT ON NATURAL TROCHLEA DOES NOT WORK). I HAVE HAD A TOTAL KNEE REPLACEMENT BUT AM FORCED TO LIVE WITH PAIN, BALANCE ISSUES, LIMITATION TO MY ACTIVITIES AND NERVE DAMAGE. I HAVE 20-30 FILMS (X-RAYS, MRIS), AND THOUSANDS OF PAGES OF MEDICAL NOTES. THERE REALLY ARE NO RELEVANT LAB TEST. FDA SAFETY REPORT ID #: (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
646773 HEMICAP PATELLA FEMORAL IMPLANT SYSTEM PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER JWH ARTHROSURFACE, INC. 2018-07 HEMI RESURFACING SYSTEM 75FC2412

Patients

Seq Age Sex Outcome Treatment
1 63 YR Other| S