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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON DEPUY DURALOC CUP
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JOHNSON AND JOHNSON DEPUY DURALOC CUP Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Disability (2371)
Event Date 04/13/2010
Event Type  No Answer Provided  
Event Description
After suffering with severe pain for over 6 years, seeking medical help but did not encounter a surgeon willing to help, until 2010.The original thr was a depuy aml with duraloc cup.In 2010, the surgeon who performed the corrective surgery informed me that i was at, and i quote, "at the cusp of catastrophic failure." the pain was unbearable, it impacted employment, loss of copulation, ability to drive and enjoy life.This version of the depuy if not recalled, should be added to the recall list because it is absolutely unacceptable that a (b)(6) woman in 1997 had a hip replacement and began to endure agonizing pain just a few years later given that hip transplants typically last 15-20 years.There was no responsibility on my part in that i did absolutely nothing to cause this pain to commence.The pain and suffering, enduring a revision surgery, and loss of six years of my life in which my marriage and child were greatly impacted should be compensated by johnson and johnson.
 
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Brand Name
DEPUY DURALOC CUP
Type of Device
DEPUY DURALOC CUP
Manufacturer (Section D)
JOHNSON AND JOHNSON
MDR Report Key3698097
MDR Text Key4269510
Report NumberMW5035185
Device Sequence Number2
Product Code LPH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/19/2014
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/20/2014
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Disability;
Patient Age46 YR
Patient Weight49
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