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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARTIVA, INC CARTIVA IMPLANT; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
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CARTIVA, INC CARTIVA IMPLANT; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT Back to Search Results
Model Number CAR-10
Device Problem Degraded (1153)
Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
 
Event Description
Allegedly it was reported that the patient underwent a surgical procedure on the toe.It was reported that the implant has worn down/subsided over time leading to a reduction of joint space.The patient will need to undergo a revision surgery.
 
Manufacturer Narrative
Additional info b5, h6; correction h6.H6: the device was not returned.Electromagnetic images were received.Review of the images does show the device is implanted in the 1st mtp joint of the right foot.According to the surgeon's notes, the patient presented on august 08, 2020 and stated "examination and x-rays today show the arthroplasty has worn somewhat and her joint space is reduced".However, product was not returned for review.Therefore, a part assessment could not be performed.
 
Event Description
Allegedly it was reported that the patient underwent a surgical procedure on the toe.It was reported that the implant has worn down/subsided over time leading to a reduction of joint space.The patient will need to undergo a revision surgery.The patients reports tolerating pain for the past 9 months.Patient remains in pain, needing pain killers, limited work and enjoyment of life.
 
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Brand Name
CARTIVA IMPLANT
Type of Device
PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
Manufacturer (Section D)
CARTIVA, INC
6120 windward parkway
suite 220
alpharetta GA 30005
MDR Report Key11008581
MDR Text Key221500280
Report Number3009351194-2020-00019
Device Sequence Number1
Product Code PNW
Combination Product (y/n)N
PMA/PMN Number
K181348
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/16/2021
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 Health Professional
Device Model NumberCAR-10
Device Lot NumberF032119001
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/18/2020
Initial Date FDA Received12/15/2020
Supplement Dates Manufacturer Received11/18/2020
Supplement Dates FDA Received04/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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