BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR METAL BACK GLENOID SMALL-R

    MDR report key: 5073879 · Received September 14, 2015

    Report

    Report Number
    3008021110-2015-00038
    Event Type
    Injury
    Date Received
    September 14, 2015
    Date of Event
    July 13, 2015
    Report Date
    August 19, 2015
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    KWS
    PMA / PMN Number
    K113254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MECHANICAL FAILURE OF THE PROSTHESIS: METAL BACK AND GLENOSPHERE WERE WELL FIXED ONE EACH OTHER WHEN CAME LOOSE FROM GLENOID BONE. THIS IS CONFIRMED BY A RADIOLOGIC EVALUATION AND BY PICTURES OF THE EXPLANTS. EXPLANTS NOT RETURNED. NO ANOMALIES DETECTED BY CHECKING THE DHR OF THE METAL BACK AND GLENOSPHERE INVOLVED. NO OTHER COMPLAINTS RECEIVED ON THESE LOT # (METAL BACK: (B)(4) PIECES MANUFACTURED; GLENOSPHERE: (B)(4) PIECES MANUFACTURED). ADDITIONAL FINDINGS BY X-RAYS EVALUATION: X-RAY DATED (B)(6) 2015 SHOWS THAT THE WHOLE CONSTRUCT COMPLETELY CAME OUT FROM THE BONE AFTER ONLY 2 MONTHS OF IMPLANTATION. ACCORDING TO A MEDICAL JUDGMENT, THE METAL BACK WAS IMPLANTED WITH AN UPPERTILT >10°. THE CAUDAL PART OF THE PROSTHESIS WAS NOT IN CONTACT WITH THE GLENOID BONE AND THE SCREWS USED DURING PRIMARY SURGERY WERE TOO SHORT TO GUARANTEE A FIRM FIXATION OF THE METAL BACK TO THE BONE. PROBABLE CAUSE OF THE INCIDENT: SUBOPTIMAL IMPLANTATION TECHNIQUE. PMS DATA: REVISION RATE ASSOCIATED TO SIMILAR EVENTS IS (B)(4); THE MAJORITY OF THESE EVENTS WAS DUE TO IMPROPER IMPLANTATION OR PATIENT TRAUMA / BONE CONDITION. TO REDUCE THE RISK OF REOCCURRENCE OF SUCH EVENTS, WE SUGGESTED TO OUR (B)(4) SUBSIDIARY TO PERFORM A FURTHER TRAINING TO THE (B)(4) SALES FORCE AND SURGEONS. LIMACORPORATE WILL KEEP THE MARKET MONITORED TO PROMPTLY DETECT POSSIBLE RECURRENCE OF SUCH EVENT. NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    SMR REVERSE IMPLANTED ON (B)(6) 2015. X-RAYS PERFORMED ON (B)(6) 2015 SHOWED METAL BACK + GLENOSPHERE COMING OFF AS A SINGLE PIECE FROM THE GLENOID BONE. REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2015. ALL SMR REVERSE COMPONENTS EXPLANTED AND REPLACED. PATIENT SUFFERED OF DEMENTIA AND DOES NOT KNOW WHEN THE INCIDENT OCCURRED. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604849 SMR METAL BACK GLENOID SMALL-R SMR METAL BACK GLENOID SMALL-R KWS LIMACORPORATE S.P.A 1375.21.005 201412714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention