FDA.reportPublic FDA data

MAUDE MDR 3434202

MDR report key
3434202
Report number
MW5032391
Event key
0
Event type
3
Date of event
2008-08-01
Date received
2013-10-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ROTATING KNEE PLATFORMROTATING KNEE PLATFORMDEPUYHRZ
2ROTATING KNEE PLATFORMROTATING KNEE PLATFORMDEPUYHRZ

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-10-2401. H; 2. S

Event Narratives#

D

Patient 1

THIS IS A DUPLICATE OF A LETTER THAT I SENT TO (B)(6) SEVERAL DAYS AGO. I PRESENT IT HERE SO THAT YOU MAY HAVE AN ELECTRONIC VERSION: DEAR (B)(6), THE PURPOSE OF MY LETTER IS TO FILE A COMPLAINT AGAINST DEPUY ORTHOPAEDICS FOR THE FAILURE OF ITS ROTATING KNEE PLATFORM. IN (B)(6) 2008, I HAD BOTH KNEES COMPLETELY REPLACED WITH THEIR PLATFORMS. BOTH HAVE HAD TO BE COMPLETELY REPLACED WITH STANDARD KNEE REPLACEMENTS. MY RIGHT KNEE WITH THEIR PLATFORM COLLAPSED AFTER ONLY SEVEN MONTHS. THE LEFT KNEE FAILED MORE GRADUALLY AND WAS REPLACED THIS (B)(6) 2013. IT CAUSED CONSIDERABLY MORE DAMAGE TO MY LEG AND FOOT OVERALL BY VIRTUE OF IT BEING IN PLACE LONGER. IN SHORT, I HAVE HAD FOUR COMPLETE KNEE REPLACEMENTS WITHIN FIVE YEARS. WITH IT HAVE COME EXTENSIVE ANCILLARY DISTRESSES. YOU MAY KNOW THIS, BUT FOR THE RECORD, THE ROTATING KNEE PLATFORM IS INHERENTLY FLAWED: THE NATURAL KNEE IS NOT BUILT TO ROTATE BEYOND A LIMITED RANGE. STUDIES SHOW THAT THE ROTATING PLATFORM DOES NOT EXTEND FLEXION AND CONSTRUCTED MOBILITY. THE ROTATING KNEE PLATFORM IS DAMAGING AND STRESSFUL TO THE KNEE/LEG/FOOT BECAUSE IT PROMOTES A BACK AND FORTH MOTION RATHER THAN THE UP AND DOWN MOVEMENT OF THE NATURAL KNEE. THE ROTATING PLATFORM DOESN'T HAVE OR SUPPORT SUFFICIENTLY STRONG HARDWARE TO SUPPORT THE KNEE/LEG/FOOT UNIT. THE SIDE EFFECTS I EXPERIENCED FROM THE DEPUY ROTATING PLATFORMS INCLUDE: FALLING DOWN WITHOUT PROVOCATION. UNCONTROLLABLE BOBBING AND WEAVING WHILE WALKING, EXTREME DIFFICULTY IN CLIMBING STAIRS DUE TO WEAKNESS OF THE ROTATING KNEE PLATFORM. AN ARRAY OF SIDE EFFECTS FROM SURGERY INCLUDING DEEP SCARRING FROM MULTIPLE INCISIONS, EXCEPTIONALLY LONG RECOVERY PERIODS FROM HAVING SURGERY ON TOP OF SURGERY. PROFOUND TENDONITIS OF THE FEET CAUSED MOSTLY BY DAMAGING ACTIONS OF THE ROTATING PLATFORMS NECESSITATING A COMPLETELY SEPARATE PHYSICAL THERAPY PROGRAM, (B)(6) OF LOST ABILITY TO WORK AND IN OUT-OF-POCKET EXPENSES RELATED TO MY KNEE REPLACEMENT. CHRONIC PAIN AND RESULTING FATIGUE. WITH FOUR KNEE REPLACEMENTS, THE ENTIRE EPISODE HAS TAKEN MORE THAN 5 YRS OF MY TIME, EXPENSE, PAIN AND GENERAL DISABILITY FOR WHICH I FEEL I SHOULD BE COMPENSATED BY DEPUY. ALSO IMPORTANT, THE ROTATING KNEE PLATFORM SHOULD BE REMOVED FROM THE MARKETPLACE. I AM CERTAIN THAT THE PHYSICIAN WHO PERFORMED BOTH OF MY KNEE REPLACEMENTS CAN ENLIGHTEN YOU ABOUT THE MEDICAL AND PHYSICAL PERILS OF THE DEPUY ROTATING KNEE PLATFORM. I AM EQUALLY CERTAIN THAT THERE ARE MANY OTHER PEOPLE WHO HAVE EXPERIENCED THE SAME OR SIMILAR FAILURES AND DISTRESSES THAT I HAVE BECAUSE OF THESE APPLIANCES.

D

Patient 1

ADD'L INFO REC'D FROM REPORTER ON 04/28/2014: I HAVE LET DEPUY KNOW THAT I HAVE CONFIRMATION NOW THAT I HAVE A SPLIT BREVIS TENDON THAT WAS CAUSED BY ONE OR MORE OF THE FALLS THAT I SUSTAINED BECAUSE OF THE FAILURE OF MY LEFT KNEE DEPUY ROTATING KNEE PLATFORM. IN THE EARLIER STAGES OF THE LEFT KNEE APPLIANCE FAILURE, I FIRST SAW A PODIATRIST FOR LEFT FOOT PAIN ON (B)(6) 2012. AFTER TRYING SOME THERAPIES, I SAW THE PODIATRIST AGAIN ON (B)(6) 2012 FOR F/U AND ADD'L THERAPIES. BY (B)(6) 2013, MY LEFT KNEE APPLIANCE WAS EVALUATED AND REVISION SURGERY TOOK PLACE IN (B)(6) 2013. WITH GOOD NEW SUPPORT, MY LEFT FOOT NO LONGER NEEDED TO BEAR THE LION'S SHARE OF THE BURDEN TO SUPPORT MY LEG AND FELT INSTANTLY BETTER, BUT TOOK A BACKSEAT TO THERAPIES FOR IT SO THAT REVISION LEFT KNEE SURGERY RECOVERY COULD TAKE PLACE. THEN, IN (B)(6) 2013 THERAPY LEVELS TO MY DAMAGED LEFT FOOT INCREASED. A NUMBER OF THERAPIES HELPED REDUCE OR RELIEVE SOME OF THE TENDONITIS PAIN. BY (B)(6), MY LEFT FOOT WAS BETTER BUT MORE HEALING NEEDED TO TAKE PLACE AND I DEVOTED THE (B)(6) 2013 TO IT. FINALLY, I COULDN'T TAKE THE PAIN ANYMORE, AND AN MRI WAS PERFORMED ON APRIL 23 OF THIS YEAR, JUST 5 DAYS AGO. IT REVEALED THE SPLIT BREVIS TENDON THAT IS AT THE CORE OF THE COLLATERAL DAMAGE OF MY FAILED DEPUY REPLACEMENT. I AM NOW SCHEDULED TO SEE MY PODIATRIST ON (B)(6), TO EXPLORE MORE FOCUSED AND ADVANCED TREATMENT OPTIONS TO HEAL THE TENDON. BUT FOR THE FAILING AND FAILED ROTATING KNEE PLATFORM, THIS INJURY TO MY FOOT WOULD NOT HAVE OCCURRED. WITH MY TWO REVISION KNEES IN PLACE, I HAVE NOT FALLEN ONCE AND THE STRENGTH OF MY REVISION KNEES ALLOWS ME TO STAND AND AMBULATE WELL AND CONFIDENTLY, SAVE FOR THE SPLIT TENDON.