MAUDE Adverse Event Report: CARTIVA, INC CARTIVA SCI; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT

Model Number CAR-10-US

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Unspecified Infection (1930); Pain (1994); Synovitis (2094); Joint Swelling (2356)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

The device was returned.Visual examination of the returned part appeared to have a partially torn portion on the articulating surface.The partial tearing of the implant is not representative of wear seen in the 5-year simulated wear of cartiva against cartilage.Since it was reported that the tearing could be seen in an mri before explanting, it is also not indicative of a removal technique such as rongeurs.This partially detached piece of the implant measured approximately 3.3mm in height and 2.4mm in width.Total device diameter was measured at an average of 10.7mm, which is within the diameter validation specification for a final, manufactured device.The height of the implant not containing this damaged portion measured at 9.5mm, which is within the validation specification for height of a final, manufactured device.The implant was weighed, resulting in a measurement of 0.8 grams, which is below the final, manufactured weight specification of 0.85g - 0.93g, indicating some mass loss.

Event Description

It was reported that during the surgery the implant was left 2mm proud.Both ap and lateral x rays looked great.Week of february 3rd: patient reported some pain and experienced a minor infection from the sutures.Reported minor puss was discharged and the doctor placed the patient on an antibiotic, which cleared everything up quickly.3 weeks later the patient is doing well and range of motion (rom) is good approximately 7 weeks post-op the patient went to see the doctor because she was experiencing severe swelling, lost rom, and pain.Doctor assumed it was maybe pain associated with the tendon and ordered and mri asap.Mri revealed the implant was tearing.Approximately 8 weeks post-op doctor had to surgically go in and remove the cartiva and backfill with a bone void filler and antibiotics.Patient suffered significant synovitis.The implant was sent to pathology and images provided of the joint being exposed prior to removal.

• Brand Name: CARTIVA SCI
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta, ga
• Manufacturer (Section G): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta, ga
• Manufacturer Contact: matthew parrish ; 1023 cherry rd; memphis, tn
• MDR Report Key: 10289924
• MDR Text Key: 199840455
• Report Number: 3009351194-2020-00002
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2020

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: Health Professional
• Device Model Number: CAR-10-US
• Device Catalogue Number: CAR-10-US
• Device Lot Number: F030719001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention