FDA Adverse Event Summary report: N

DEPUY ASR HIP CUP

MDR report key: 2993961 · Received February 27, 2013

Report

Report Number
MW5029223
Date Received
February 27, 2013
Date of Event
May 1, 2009
Report Date
February 27, 2013
Manufacturer
DEPUY ORTHOPEDICS
Product Code
KWA
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MN, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

DUE TO END STAGE RIGHT HIP DEGENERATIVE JOINT DISEASE RELATED TO CAM II TYPE IMPINGEMENT, I RECEIVED A THA ON (B)(6) 2009. I RECEIVED THE DEPUY J&J ORTHO ASR IMPLANTS. THE FOLLOWING DEVICES MODEL #S WERE IMPLANTED: 1570-12-135 STEM, 9998-00-312 SLEEVE, 9998-00-758 ACETABULAR CUP, 9998-90-251 FEMORAL UNI-SZ 51. PRIOR TO SURGERY I WAS SEVERELY RESTRICTED IN HIP ROM; BOTH ACTIVE AND PASSIVE AS WELL AND UNRELENTING PAIN THROUGHOUT THE DAY AND NIGHT. INITIALLY POST-OP, I EXPERIENCED A SIGNIFICANT IMPROVEMENT IN MY QUALITY OF MOVEMENTS AS WELL AS LIFE ACTIVITIES. OVER THE COURSE OF THE PAST 24 MONTHS, I HAVE AGAIN STARTED EXPERIENCING SEVERE PAIN WITH MANY WEIGHT-BEARING ACTIVITIES; INCLUDING WALKING, STAIRS ASCENT/DESCENT AND TRANSFERS. I ALSO AM BEGINNING TO EXPERIENCE LOSS IN HIP ROM AND JOINT/GROIN PAIN AT REST. I HAVE ALSO HAD A SIGNIFICANT CHANGE IN THE JOINT STABILITY. APPROX 2 YEARS AGO, I BEGAN TO NOTICE A GRINDING AND CLUNKING SENSATION WITH HIP MOTIONS. THIS SENSATION HAS CONTINUED TO INCREASE AND NOW IS NOTICED WITH NEARLY ALL HIP FUNCTIONS AND MOVEMENTS. I ALSO HAVE EXPERIENCED A SIGNIFICANT INCREASE IN MID THORACO-LUMBAR BACK PAIN AND STIFFNESS. EVEN WITH THE IMPLEMENTATION OF STRETCHING AND CORE STABILIZATION EXERCISES, THE BACK PAIN IS UNRELENTING. IT SHOULD ALSO BE NOTED, WHETHER DIRECTLY RELATED OR NOT, THE EXPERIENCE OF A PSEUDO-RESTLESS-LEGS PHENOMENON. MY RIGHT LEG FEELS AS IF IT NEEDS TO BE IN A STATE OF CONSTANT VIBRATORY MOTION. ALTHOUGH I CAN VOLUNTARILY STOP THE MOVEMENT, THE MAJORITY OF THE TIME IT TWITCHES OR IS IN MOVEMENT. DATES OF USE: (B)(6) 2009- (B)(6) 2013 (PRESENT). DIAGNOSIS OR REASON FOR USE: HIP OSTEOARTHRITIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
83558 DEPUY ASR HIP CUP HIP IMPLANT CUP KWA DEPUY ORTHOPEDICS 9998-00-758 2647780
83559 DEPUY HIP STEM HIP IMPLANT STEM KXA DEPUY ORTHOPEDICS 1570-12-135 2850316
83560 DEPUY HIP SLEEVE HIP IMPLANT SLEEVE KWA DEPUY ORTHOPEDICS 9998-00-312 27177
83561 DEPUY FEMORAL UNI-SZ 51 HIP IMPLANT FEMORAL KWA DEPUY ORTHOPEDICS 9998-90-251

Patients

Seq Age Sex Outcome Treatment
1 43 YR Hospitalization| R| S