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 Problems Loss of Range of Motion (2032); Implant Pain (4561)

Event Date 02/05/2019

Event Type  Injury  

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.

Event Description

It was reported through the filing of a lawsuit that allegedly on (b)(6) 2017, during the revision cheilectomy, acumed cement was placed in the hole to a depth of 3 cm and the new cartiva implant was press-fitted with 2.5-3mm along the sides.It is alleged that the patient continued to have great toe pain and stiffness and on (b)(6) 2019, underwent a second hallux mtp joint cheilectomy, first metatarsophalangeal joint debridement, and plantar plate debridement.It is alleged that during this surgery the second cartiva implant had moved to -1.5mm of the joint.

• 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: 14322519
• MDR Text Key: 294660909
• Report Number: 3009351194-2022-00104
• 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): Hospitalization; Required Intervention
• Patient Sex: Male