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

Catalog Number UNK_WCA

Device Problem Migration (4003)

Patient Problem Loss of Range of Motion (2032)

Event Date 12/05/2017

Event Type  Injury  

Event Description

It was reported through the filing of a lawsuit that allegedly on or about (b)(6) 2017, the patient underwent a right 1st metatarsal joint cheilectomy with a cartiva 10 x 10 implant.It is further alleged that three months later, a post operative ct scan revealed arthrofibrosis with impingement of the 1st metatarsophalangeal joint and on (b)(6) 2017, he underwent a revision cheilectomy.It is alleged that during this surgery the cartiva was noted to be flush with the mtp joint.

Manufacturer Narrative

The reported device is not available as it is the subject of a legal matter.If additional information becomes available, it will be provided in a supplemental report.

• Brand Name: UNKNOWN WRIGHT 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14322563
• MDR Text Key: 294660358
• Report Number: 3009351194-2022-00103
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2022

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: Lay User/Patient
• Device Catalogue Number: UNK_WCA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/07/2022
• 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; Hospitalization
• Patient Sex: Male