BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMR CTA HUMERAL HEAD 46 MM

    MDR report key: 10161965 · Received June 17, 2020

    Report

    Report Number
    3008021110-2020-00040
    Event Type
    Malfunction
    Date Received
    June 17, 2020
    Date of Event
    June 4, 2020
    Report Date
    October 16, 2020
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    HSD
    PMA / PMN Number
    K110847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF THE DHR: BY CHECKING THE DHR OF THE LOT#0908109, NO PRE-EXISTING ANOMALY WAS DETECTED. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. EXPLANTS ANALYSIS: EXPLANTED COMPONENTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR INVESTIGATION. XRAYS ANALYSIS: WE RECEIVED XRAY IMAGES DATED (B)(6) 2020 AND PICTURE OF THE EXPLANTS AND SHARED THEM WITH OUR MEDICAL CONSULTANT FOR ANALYSIS. FOLLOWING, HIS OPINION IS REPORTED: "[[..]] THE PROSTHESIS HAS BEEN IMPLANTED FOR TEN YEARS SO SIMILAR TO THE OTHER CASE IT IS REASONABLE TO ASSUME THE OUTCOME WAS "ACCEPTABLE" FOR THE PATIENT UNTIL SOME TIME IN THE RECENT PAST WHEN IT HAS BECOME UNACCEPTABLE? AS YOU KNOW AS A GENERALISATION THE OUTCOME OF CTA HEAD IS OCCASIONALLY ACCEPTABLE BUT USUALLY NOT. THE OTHER POSSIBILITY IS THE PATIENT HAS TOLERATED AN UNSATISFACTORY OUTCOME FOR THE DURATION. THE IMAGES SHOW THAT TECHNICALLY THE PROCEDURE HAS BEEN CARRIED OUT WELL. THERE IS SOME MILD REMODELLING CHANGE IN THE HUMERUS, THERE IS SOME BONEY WEAR IN THE GLENOID BUT THERE IS NOTHING IN THAT MOST RECENT XRAY TO INDICATE A REASON FOR A REDUCED OUTCOME. I CANNOT SEE ANY PATIENT FACTOR TO ACCOUNT FOR THE DECLINE." ACCORDING TO THE MEDICAL EXPERT, XRAYS TAKEN 5 MONTHS BEFORE SURGERY DID NOT SHOW ANY ANOMALY IN PROSTHESIS POSITIONING AND IN PATIENT CONDITION. HE HYPOTHESIZED THAT PATIENT HAS STARTED FEELING THE OUTCOME UNACCEPTABLE 10 YEARS AFTER IMPLANTATION FOR A NOT SPECIFIC REASON. OTHERWISE, THE PATIENT HAS TOLERATED AN UNSATISFACTORY OUTCOME FOR THE DURATION. AT THIS STAGE, IT IS NOT POSSIBLE TO INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THE LACK OF SIMILAR COMPLAINTS ON THE SAME LOT# AND THE DURATION OF THE PROSTHESIS (10 YEARS) WE CAN CONCLUDE THAT THIS EVENT IS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, OCCURRENCE RATE OF CTA REVISION FOR CUFF FAILURE IL 0.16%. NONE OF THESE CASES WAS JUDGED AS PRODUCT RELATED. NO CORRECTIVE ACTION IMPLEMENTED DUE TO THIS SPECIFIC CASE. LIMACORPORATE WILL KEEP THE MARKET MONITORED.

    Description of Event or Problem · 0

    REVISION SURGERY OF CTA HEAD DUE TO CUFF FAILURE PERFORMED ON (B)(6) 2020. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2010. DURING REVISION SURGERY, CTA HEAD (PRODUCT CODE 1323.09.460, LOT# 0908109, STER. 1000067) AND HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT# 1002796, STER. 1000155) WERE REMOVED AND HEMI PROSTHESIS WAS CONVERTED TO REVERSE. NO ADDITIONAL INFORMATION AVAILABLE. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT#0908109, NO PRE-EXISTING ANOMALY WAS DETECTED. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT#. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    REVISION SURGERY OF CTA HEAD DUE TO CUFF FAILURE PERFORMED ON (B)(6) 2020. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2010. DURING REVISION SURGERY, CTA HEAD CODE 1323.09.460 (LOT 0908109, STER. 1000067) AND HUMERAL BODY 1350.15.110 WERE REMOVED AND HEMI PROSTHESIS WAS CONVERTED TO REVERSE. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629397 SMR CTA HUMERAL HEAD 46 MM SMR CTA HUMERAL HEAD Ø46 MM HSD LIMACORPORATE SPA 1323.09.460 0908109

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention