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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES, INC. / JOHNSON AND JOHNSON PINNACLE "COMPLETE" CERAMIC-ON-METAL HIP PROSTHESIS INCLUDING ULTAMET METAL LINI; METAL, CERAMIC, POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
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DEPUY SYNTHES, INC. / JOHNSON AND JOHNSON PINNACLE "COMPLETE" CERAMIC-ON-METAL HIP PROSTHESIS INCLUDING ULTAMET METAL LINI; METAL, CERAMIC, POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED Back to Search Results
Device Problem Defective Component (2292)
Patient Problems Hearing Loss (1882); Memory Loss/Impairment (1958); Pain (1994); Swelling (2091); Visual Disturbances (2140); Toxicity (2333)
Event Date 04/05/2018
Event Type  Injury  
Event Description
Diagnosed with metal poisoning from defective metal lining coated with cobalt and chromium in depuy pinnacle complete ceramic-on-metal left hip implant, original surgery (b)(6) 2011.Necessitated removal, revision and debridement (b)(6) 2018.I have associated cobalt toxicity symptoms of afib, memory and concentration issues, hearing loss, vision problems, muscle mass loss, muscle cramps and metallic taste and loss of taste.Ongoing pain, swelling and lymphatic issues following (b)(6) 2018 surgery.Tentative ablation surgery scheduled for (b)(6) 2018.Right hip also has this implant and we are monitoring for issues with ongoing blood tests and optic nerve exams every 6 months.
 
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Brand Name
PINNACLE "COMPLETE" CERAMIC-ON-METAL HIP PROSTHESIS INCLUDING ULTAMET METAL LINI
Type of Device
METAL, CERAMIC, POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Manufacturer (Section D)
DEPUY SYNTHES, INC. / JOHNSON AND JOHNSON
MDR Report Key8009066
MDR Text Key125325839
Report NumberMW5080836
Device Sequence Number1
Product Code LZO
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 10/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age61 YR
Patient Weight59
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