MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Device Problem Material Fragmentation (1261)

Patient Problems Pain (1994); Swelling (2091)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

The product catalog and lot number of the device involved in this event was not made available.As a result, a review of the quality and manufacturing records for the involved product lot could not be carried out.The returned device was evaluated.The visual evaluation found significant and uneven scratching and wear along the circumference of the articulating surfaces and along the top of the lateral sides of the device nearing the radiused edge, and what appears to be areas of material loss, inconsistent with that observed in the cartiva on cartilage wear study which simulated 5-year use.The maximum height and diameter of the device were measured and found within the post-sterilization value range established through validation of the manufacturing process.The degree and manifestation of wear and material loss is not representative of that seen in the 5-year simulated wear of cartiva against cartilage and is not consistent with damage of the device by a removal technique, such as rongeurs.A possible contributing factor to the atypical wear exhibited by this device may be the initial device protuberance of 5.0 mm reported by the implanting physician, as described in the surgery notes made available for evaluation.However, performance and potential failure modes of the cartiva device material at a proudness of 5.0 mm has not been characterized.Therefore, no definite evidence of device failure or nonconformance could be identified, nor a root cause could be found.

Event Description

Feedback received from surgeon where they reported an implant removal.According to the information received, the subject received a 10 mm cartiva implant on her left mtp joint on (b)(6) 2019, without issue.The lot number for the involved device was not made available.At the time of surgery, the implant was noted to be seated securely in the metatarsal head with 5mm of protuberance in the metatarsophalangeal joint.The patient reported swelling and continued pain approximately 2 months postoperative.Following, electromagnetic images taken of the operated area approximately 6 months postoperative suggested radioopacity in the dorsal aspect of the joint, raising a concern for possible fragmentation of the device.Finally, the patient underwent successful implant removal and revision to fusion on (b)(6) 2019.

• Brand Name: CARTIVA SCI
• Type of Device: CARTIVA SCI
• Manufacturer (Section D): CARTIVA, INC.; 6120 windward parkway; suite 220; alpharetta GA 30005
• Manufacturer (Section G): CARTIVA, INC.; 1005 alderman drive; suite 208; alpharetta GA 30005
• Manufacturer Contact: pablo mercado ; 6120 windward parkway; suite 220; alpharetta, GA 30005 ; 7707543853
• MDR Report Key: 9323665
• MDR Text Key: 168448315
• Report Number: 3009351194-2019-00025
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/14/2019
• 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
• Patient Age: 56 YR