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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARTIVA, INC./WRIGHT MEDICAL TECHNOLOGY, INC. CARTIVA SYNTHETIC CARTILAGE IMPLANT; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
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CARTIVA, INC./WRIGHT MEDICAL TECHNOLOGY, INC. CARTIVA SYNTHETIC CARTILAGE IMPLANT; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT Back to Search Results
Device Problem Malposition of Device (2616)
Patient Problems Inflammation (1932); Pain (1994); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/29/2018
Event Type  Injury  
Event Description
Had to have a second surgery; i got a cartiva synthetic cartilage implant on (b)(6) 2018.After recovering as directed by my doctor, i was allowed to resume walking.The pain in my mtp joint was much worse than before i had the surgery.I did physical therapy, dry needling with electric stimulation, and even tried medical massage therapy.I could not get relief from the intense pain.I developed it band syndrome and bursitis in my hip due to my altered gait.The orthopedic surgeon finally confirmed 9 months after surgery that the implant had receded into the bone, and i was back to bone on bone in that joint.In (b)(6) 2019 i had the cartiva removed and the surgeon placed a plate and seven screws in the bone to fuse the bones together.After having the hardware removed in (b)(6) 2020, i am finally feeling relief.Fda safety report id # (b)(4).
 
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Brand Name
CARTIVA SYNTHETIC CARTILAGE IMPLANT
Type of Device
PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
Manufacturer (Section D)
CARTIVA, INC./WRIGHT MEDICAL TECHNOLOGY, INC.
MDR Report Key11019067
MDR Text Key222079917
Report NumberMW5098392
Device Sequence Number1
Product Code PNW
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/12/2020
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 No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/15/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age51 YR
Patient Weight66
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