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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL / CARTIVA, INC. CARTIVA; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT

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WRIGHT MEDICAL / CARTIVA, INC. CARTIVA; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT Back to Search Results
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem Pain (1994)
Event Date 03/29/2018
Event Type  Injury  
Event Description
I had cartiva implant surgery done on (b)(6) 2018.My pain was never relieved and has gotten worse since then.My cartiva is a failure and surgeon says it needs to be removed and my toe needs to be fused.Surgeon took an x-ray on (b)(6) 2019 and deemed the cartiva to be a failure.It had receded in to my bone.Fda safety report id# (b)(4).
 
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Brand Name
CARTIVA
Type of Device
PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
Manufacturer (Section D)
WRIGHT MEDICAL / CARTIVA, INC.
MDR Report Key9008719
MDR Text Key158599371
Report NumberMW5089746
Device Sequence Number1
Product Code PNW
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 09/09/2019
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/11/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age48 YR
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