CARTIVA IMPLANT 10MM

Description of Event or Problem

IT WAS REPORTED BY PATIENT'S COUNSEL THAT ALLEGEDLY ON (B)(6) 2018, THE PATIENT UNDERWENT RIGHT FIRST METATARSOPHALANGEAL CHEILECTOMY, DEBRIDEMENT AND CAPSULAR RELEASE AND WAS IMPLANTED WITH A 10MM CARTIVA IMPLANT.

Additional Manufacturer Narrative

CORRECTION: D2A (COMMON DEVICE NAME), D2B (PRODUCT CODE), H6 (METHOD). THE COMPLAINT COULDN'T BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. 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. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

Additional Manufacturer Narrative

UPON COMPLETION OF THE INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED BY PATIENT'S COUNSEL THAT ALLEGEDLY ON (B)(6), 2018, THE PATIENT UNDERWENT RIGHT FIRST METATARSOPHALANGEAL CHEILECTOMY, DEBRIDEMENT AND CAPSULAR RELEASE AND WAS IMPLANTED WITH A 10MM CARTIVA IMPLANT.