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

Model Number CAR-10

Device Problem Unintended Movement (3026)

Patient Problems Osteolysis (2377); Joint Laxity (4526)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

The product was returned for review.The visual evaluation found scratches on the lateral surface and two pin holes on the articulating surface, the latter likely occurring during the revision surgery.A smooth depression with unidirectional scuffing on one side of the articulating surface was inconsistent with the scuffing observed in the cartiva on cartilage wear study which simulated the equivalent of 5 years of use was found.The height of the device was measured and found to be within the post-sterilization value range.The device diameter measured slightly below the validated post-sterilization values.More detail is available on the attached report.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.

Event Description

The surgeon reported that they suspect implant subsidence on an un-identified patient approximately one year postoperatively.The exact date of implant is currently unknown.The surgeon suspects the implant may be subsiding due to osteolysis.

• 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: 13606566
• MDR Text Key: 286227091
• Report Number: 3009351194-2022-00027
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2021

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 Expiration Date: 05/31/2019
• Device Model Number: CAR-10
• Device Lot Number: F050417001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2017
• 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): Other
• Patient Age: 43 YR
• Patient Sex: Male