UNKNOWN CARTIVA IMPLANT
Received Oct 29, 2024 · Event occurred Oct 14, 2024
Report 3009351194-2024-00015 · MDR key 20554634
Device
Generic name
Prosthesis, Toe, Hemi-, Phalangeal
Manufacturer
Cartiva, IncCatalog number
UNK_WCA
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE KING'S COLLEGE HOSPITAL NHS FOUNDATION TRUST. THE TITLE OF THIS REPORT IS HOW DOES CARTIVA INTERPOSITIONAL ARTHROPLASTY COMPARE TO ARTHRODESIS IN THE TREATMENT OF HALLUX RIGIDUS? A RETROSPECTIVE COMPARATIVE STUDY WITH 12-MONTH FOLLOW-UP, PUBLISHED IN 2024, WHICH IS ASSOCIATED WITH THE STRYKER CARTIVA SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1302/1358-992X.2024.11.023. THIS REPORT INCLUDES ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 17 PATIENTS. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND AT THIS TIME NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT 1 PATIENT HAD TO BE REOPERATED.
Additional Manufacturer Narrative
THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING THE POST-MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED EVENT COULD NOT BE CONFIRMED, SINCE NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR OR THE ARTICLE. MORE DETAILED INFORMATION ABOUT THE PATIENT MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, AND MEDICAL REPORTS MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.