UNKNOWN FUTURA CONICAL SUBTALAR CSI IMPLANT RIGHT FOOT
Received Nov 30, 2022 · Event occurred Nov 4, 2022
Report 0001649390-2022-00108 · MDR key 15889256
Device
Generic name
Prosthesis, Toe, Hemi-, Phalangeal
Manufacturer
Tornier IncCatalog number
UNK_WTB
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Implant Pain
- Implant Pain
Narrative
Additional Manufacturer Narrative
THE REPORTED EVENT REGARDING PERSISTENT PAIN BILATERALLY AT THE SINUS TARSI, WHICH WAS SOLVED WITH SCREWS REMOVAL AFTER 2 AND 5 YEARS, COULD NOT BE CONFIRMED, SINCE THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.
Description of Event or Problem
THE POST MARKET CLINICAL TEAM HAS CONDUCTED A FOLLOW-UP REPORT ON ¿RADIOGRAPHIC CLINICAL OBSERVATIONAL STUDY ON PATIENTS TREATED FOR FLAT FOOT ¿. THE STUDY WAS CONDUCTED AT ¿IRCCS ISTITUTO ORTOPEDICO GALEAZZI, ITALY¿. THE REPORT IS ASSOCIATED WITH THE STRYKER ¿FUTURA CONICAL SUBTALAR IMPLANT SYSTEM (CSI) ¿ AND INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 40 PATIENTS. THE CASES IN THE STUDY RANGE FROM JANUARY 2005 TO MAY 2016. THE REPORT INDICATES THAT 1 PATIENT EXPERIENCED PERSISTENT PAIN BILATERALLY AT THE SINUS TARSI WHICH WAS SOLVED WITH SCREWS REMOVAL AFTER 2 AND 5 YEARS.