BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CTA HUMERAL HEAD (COCRMO) DIA.42MM

    MDR report key: 6928072 · Received October 9, 2017

    Report

    Report Number
    3008021110-2017-00093
    Event Type
    Injury
    Date Received
    October 9, 2017
    Date of Event
    August 4, 2017
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    PMA / PMN Number
    K110847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO ANOMALIES DETECTED BY CHECKING THE MANUFACTURING CHART RELATED TO LOT# 201509276, ON A TOTAL OF 23 CTA HUMERAL HEADS MANUFACTURED WITH THIS LOT#. ADDITIONALLY, 9 OUT OF THE 23 CTA HUMERAL HEADS MANUFACTURED WITH THIS LOT# WERE IMPLANTED WITHOUT RECEIVING ANY OTHER COMPLAINT ON THIS LOT#. NO EXPLANTS NOR X-RAYS WERE AVAILABLE TO BE PROVIDED TO LIMACORPORATE. WE ARE NOT AWARE OF THE ROOT CAUSE FOR THE FIRST REVISION SURGERY OCCURRED ON (B)(6) 2016 (WHEN A SMR ANATOMIC HEMI WITH CTA HEAD WAS IMPLANTED); AS PER OUR IFU AND SURGICAL TECHNIQUE, A CTA HUMERAL HEAD IS INDICATED IN CASE OF CUFF TEAR ARTHROPATHY. WE CANNOT GO BACK WITH CERTAINTY TO THE CAUSES OF THE ROTATOR CUFF FAILURE REPORTED AFTER THE 1ST REVISION. ACCORDING TO THE CHECK OF THE MANUFACTURING CHART, WE CAN EXCLUDE THAT THIS SECOND REVISION - CONVERSION FROM SMR ANATOMIC HEMI TO SMR REVERSE - WAS RELATED TO THE PROSTHESIS ITSELF (NO PRODUCT'S ANOMALY). BASED ON OTHER SIMILAR EVENTS REPORTED, PATIENT'S CONDITIONS AND/OR SURGICAL FACTORS ARE POSSIBLE CONTRIBUTORY CAUSES FOR THIS ISSUE. BASED ON THE FEW INFO RECEIVED, A DEEPER ANALYSIS ON THIS CASE IS NOT POSSIBLE. PMS DATA: A TOTAL OF 5 CONVERSIONS FROM SMR ANATOMIC HEMI WITH CTA HEAD TO SMR REVERSE DUE TO CUFF FAILURE WERE REPORTED TO LIMACORPORATE ON A TOTAL OF ABOUT 4.120 CTA HEADS BELONGING TO THE FAMILY 1323.09.XXX SOLD WW FROM 2004. THIS GIVES A REVISION RATE OF (B)(4) . EVENTS NOT PRODUCT-RELATED. NO CORRECTIVE ACTION PLANNED FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY SIMILAR ISSUE.

    Description of Event or Problem · 0

    SECOND SHOULDER REVISION SURGERY DUE TO ROTATOR CUFF FAILURE (PATIENT PAIN AND LOSS OF RANGE OF MOTION) PERFORMED ON (B)(6) 2017. ACCORDING TO THE INFO REPORTED, PATIENT UNDERWENT THE FOLLOWING SURGERIES IN TIME: PRIMARY SURGERY ON (B)(6) 2015: SMR ANATOMIC PROSTHESIS WAS IMPLANTED; FIRST REVISION SURGERY ON (B)(6) 2016: SMR ANATOMIC HEMI WITH A CTA HUMERAL HEAD - MODEL# 1323.09.420, LOT# 201509276 - WAS IMPLANTED; CAUSE OF THE 1ST REVISION IS UNKNOWN; SECOND REVISION SURGERY ON (B)(6) 2017: SMR ANATOMIC HEMI WITH CTA HEAD WAS CONVERTED TO A SMR REVERSE IMPLANT. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    NO ANOMALIES DETECTED BY CHECKING THE MANUFACTURING CHART RELATED TO LOT# 201509276. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED BY LIMA CORPORATE ON THIS SPECIFIC LOT# ON A TOTAL OF (B)(4) PIECES MANUFACTURED WITH THIS LOT#. WE WILL SEND A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY DUE TO ROTATOR CUFF FAILURE DONE ON (B)(6) 2017. ACCORDING TO THE INFO REPORTED, THE CTA HUMERAL HEAD (MODEL# 1323.09.420, LOT# 201509276) IMPLANTED DURING THE PRIMARY SURGERY DONE ON (B)(6) 2016 WAS REPLACED AND A CONVERSION FROM SMR ANATOMIC HEMI TO SMR REVERSE PROSTHESIS WAS DONE. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707502 CTA HUMERAL HEAD (COCRMO) DIA.42MM CTA HUMERAL HEAD (COCRMO) DIA.42MM, HSD, KWS HSD LIMACORPORATE S.P.A. 1323.09.420 1509276

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention