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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. WRIGHT MEDICAL CONSERVE PLUS HIP RESURFACING; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTED OR NON-POROUS UNC
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WRIGHT MEDICAL TECHNOLOGY, INC. WRIGHT MEDICAL CONSERVE PLUS HIP RESURFACING; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTED OR NON-POROUS UNC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Hearing Impairment (1881); Toxicity (2333); Shaking/Tremors (2515); Cognitive Changes (2551)
Event Date 08/23/2018
Event Type  Injury  
Event Description
"3637_mom_conserve plus", pt received a wright medical conserve plus left hip resurfacing in (b)(6) 2000 by dr (b)(6).He notes no symptoms at the hip.Plain x-rays of the hip made on (b)(6) 2018, showed a well-positioned left hip resurfacing with no evidence of loosening or lysis.On (b)(6) 2018, his urine cobalt level was 17.1 mcg/l and his blood cobalt level was 0.7 mcg/l.He noted cognitive changes, especially after general anesthesia, decreased energy level, decline in hearing, balance issues, and he exhibited a fine rest tremor.Neuro q analysis of his fdg pet brain scan indicated pronounced general and focal hypometabolism suggestive of chronic toxic encephalopathy.Fda safety report id# (b)(4).
 
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Brand Name
WRIGHT MEDICAL CONSERVE PLUS HIP RESURFACING
Type of Device
PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTED OR NON-POROUS UNC
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
MDR Report Key9627150
MDR Text Key176431565
Report NumberMW5092469
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 Non-Healthcare Professional
Type of Report Initial
Report Date 01/21/2020
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? Yes
Device Operator Lay User/Patient
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/23/2020
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age75 YR
Patient Weight93
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