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

Model Number 10 MM CARTIVA

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

Patient Problem Discomfort (2330)

Event Date 06/21/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, the patient underwent an operative procedure to remove the implant and revise the 1st mtp joint to fusion.The patient was approximately 77 months post-op from their initial procedure.(motion study patient (b)(6)).

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.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 SCI IMPLANT
• 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: 13606403
• MDR Text Key: 287424901
• Report Number: 3009351194-2022-00026
• 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,Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2018

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: 10 MM CARTIVA
• Device Catalogue Number: CAR-10
• Device Lot Number: F031010001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2018
• 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): Other
• Patient Age: 73 YR
• Patient Sex: Female