MAUDE Adverse Event Report: CARTIVA, INC CARTIVA DEVICE 10MM T20-0388; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT

Catalog Number CAR-10

Device Problem Migration (4003)

Patient Problems Discomfort (2330); Implant Pain (4561)

Event Date 07/06/2017

Event Type  Injury  

Event Description

The claimant was implanted with the cartiva implant.It was found that the implant had subsided 3 years post-op, causing the claimant pain and discomfort, as well as causing her to have to undergo further remedial procedures.

Manufacturer Narrative

The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.H3 other text : device remains implanted in patient.

Event Description

The claimant was implanted with the cartiva implant.It was found that the implant had subsided 3 years post-op, causing the claimant pain and discomfort, as well as causing her to have to undergo further remedial procedures.

Manufacturer Narrative

The reported event (implant - loosening postoperative) could be confirmed, since review of medical records provided did find the treating surgeon confirmed the implant had subsided.Although medical records provided were able to confirm the allegation of implant subsidence, no definitive root causes could be extracted from these documents.The patient had a history of procedures performed at the implant site and surrounding anatomy.There was also a patient fall noted prior to the patient's first revision surgery of the screws and staples.It was noted that the patient's postoperative healing process after implant was unremarkable until the impact trauma.Medical affairs was also consulted on the details of this case.According to their review, "the documentation of the surgeons and the involved medical health care personnel is pretty comprehensive, but i did not reveal anything which could help identify a specific cause for the failure." more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: CARTIVA DEVICE 10MM T20-0388
• 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: 17790073
• MDR Text Key: 323946308
• Report Number: 3009351194-2023-00017
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

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: 04/01/2018
• Device Catalogue Number: CAR-10
• Device Lot Number: F033016001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2016
• 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 Sex: Female