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

Model Number CAR-10

Device Problems Malposition of Device (2616); Unintended Movement (3026)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 05/11/2016

Event Type  Injury  

Event Description

At 46 months after implant subject had device removed and was converted to fusion.

Manufacturer Narrative

The product was returned for review.Visual examination found scratches on the lateral surface and an abrasion was observed at the edge of the articulating surface.The height of the device still matched the post-sterilization value range.The diameter was slightly lower than the validated post-sterilization value as the device had experienced constant radial pressure while implanted.It is suspected that the positioning of the implant contributed to altered loading and possible depression of the implant surface; however this cannot be definitively confirmed.On november 10th, 2020 stryker trauma and extremities acquired cartiva, wright medical, tornier inc.And tornier sas.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.

• Brand Name: CARTIVA
• Type of Device: PROSTESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA; 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: 13606266
• MDR Text Key: 287426715
• Report Number: 3009351194-2022-00009
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2021

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: Lay User/Patient
• Device Model Number: CAR-10
• Device Lot Number: F032811003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 02/25/2022
• 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: 58 YR
• Patient Sex: Female