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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

The returned device was not submerged in liquid.The device appeared to be dehydrated and exhibited a yellowish, translucent hue.Initial evaluation was conducted on the device as it was returned, seemingly dehydrated.The device feels firmer than a sterile, manufactured device but not as stiff as a fully dehydrated device.Visual examination revealed scuff marks on the side and the base of the implant, which may have been the result of friction against the bone cavity during the implant removal.Slanted indentations were found on the side of the dehydrated implant at a 10° measured angle from the implant base, possibly caused by device compression against the rim of the bone cavity.The angle of the indentation may be the result of non-perpendicular implantation in the metatarsal head.There appeared to be no guide pin holes in the device, suggesting implant removal by other means.The articulating surface had crevices that were smooth, segmented, and reflective.This wear pattern is not consistent with the scuffing seen in testing to simulate the equivalent of 5 years use.The device was left to rehydrate in 0.9% sterile saline for 24 hours.After rehydration, the device swelled slightly and exhibited a translucent, whitish hue.The scuff marks and wear patterns remained consistent after rehydration.After rehydration, both the height (9.5 mm) and the diameter (10.2 mm) of the device fell within the specifications of a sterile, manufactured 10mm cartiva device (9.0 mm 10.3 mm for height and 10.2 mm 11.0 mm for diameter.The mass of the device 0.8 was slightly lower than the mass data recorded from sterile, manufactured devices (0.85 - 0.93g), indicating measurable mass loss in the device, attributable to the areas of material loss characterized above.Based on the available visual and dimensional observations of the returned device, no definitive root cause could be identified regarding the reported event.On november 10st 2020 stryker trauma and extremities acquired cartiva, wright medical, tornier inc.And tornier (b)(4).An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr/vigilance process.

Event Description

It was reported that the patient underwent a surgical procedure.It was reported that the patient underwent a revision surgery.

• 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
• Manufacturer (Section G): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• Manufacturer Contact: matthew parrish ; 1023 cherry rd; memphis, TN 38117
• MDR Report Key: 13606099
• MDR Text Key: 290531022
• Report Number: 3009351194-2022-00067
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2019

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female