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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES, INC. PINNACLE METAL ON METAL HIP; PROSTHESIS, HIP
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DEPUY SYNTHES, INC. PINNACLE METAL ON METAL HIP; PROSTHESIS, HIP Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Debris, Bone Shedding (1803); Itching Sensation (1943); Necrosis (1971); Neuropathy (1983); Pain (1994); Rash (2033); Sepsis (2067); Anxiety (2328); Depression (2361); Cognitive Changes (2551); Test Result (2695); No Code Available (3191)
Event Date 04/21/2018
Event Type  Injury  
Event Description
Received a metal on metal hip replacement 2006, went for 12 years to multiple doctors who refused to take care of me.Severe worsening pain from the day it was placed until (b)(6) 2018.In this time i experienced pain, neuropathy, rashes, itching, anxiety, depression, cognitive issues, made fun of for years because of the noises the hip made with every step.All doctors ever did were x-rays and they always stated the hip was in place.The fda allowed this device into the market and i have been severely injured and have lifelong disabilities because of this metal on metal hip.Now completely unable to return to my career as a registered nurse.Metal levels over 49, sepsis, pseudotumors, necrosis and bone loss.Antibiotic spacer placed (b)(6) 2018 for over 8 months and revision on (b)(6) 2018.All completed at (b)(6) medical center, (b)(6).
 
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Brand Name
PINNACLE METAL ON METAL HIP
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
DEPUY SYNTHES, INC.
MDR Report Key8366345
MDR Text Key137319431
Report NumberMW5084283
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/21/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention; Disability;
Patient Age48 YR
Patient Weight93
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