BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENTED GLENOID SMALL

    MDR report key: 10558990 · Received September 21, 2020

    Report

    Report Number
    3008021110-2020-00068
    Event Type
    Injury
    Date Received
    September 21, 2020
    Date of Event
    September 14, 2020
    Report Date
    April 14, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 51 ITEMS MANUFACTURED WITH LOT# 1000948. NO OTHER COMPLAINTS RECEIVED ON THIS SPECIFIC LOT NUMBER. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY THE FOLLOWING INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE BUT IT WAS NOT AVAILABLE: PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY; CLINICAL DATA FOR THE PATIENT. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, STATING THAT: · THE CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT# 1000948; · ACCORDING TO THE SURGEON RESPONSIBLE FOR THIS CONVERSION SURGERY (DIFFERENT FROM THE ONE RESPONSIBLE FOR THE FIRST REVISION SURGERY), THE ANATOMIC PROSTHESIS IMPLANTED FAILED FOR THE SECOND TIME SINCE THE GLENOID METAL BACK WAS NOT RECTIFIED DURING THE FIRST REVISION SURGERY; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, THE ESTIMATED REVISION RATE OF SMR ANATOMIC TOTAL PROSTHESIS DUE TO DISLOCATION IS 0,10%. NO SPECIFIC CORRECTIVE ACTIONS IMPLEMENTED IN RELATION TO THIS CASE. LIMA CORPORATE WILL KEEP MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    CONVERSION FROM A SMR ANATOMIC TOTAL TO SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2020 DUE TO DISLOCATION AND PAIN. CLINICAL HISTORY OF THE PATIENT: PRIMARY SURGERY PERFORMED ON (B)(6), 2011. AT THIS TIME, SMR ANATOMIC TOTAL PROSTHESIS WAS IMPLANTED; FIRST REVISION SURGERY PERFORMED ON (B)(6), 2017 DUE TO PAIN AND LOSS OF ROM. AT THIS TIME, SURGEON BELIEVED GLENOID METAL BACK WAS LOOSE DUE TO PATIENT SYMPTOMS AND RADIOLOGY REPORT. HOWEVER, INTRAOPERATIVELY, GLENOID METAL BACK WAS FOUND TO BE SOLIDLY FIXED SO THE SURGEON DECIDED TO REPLACE ONLY THE HUMERAL HEAD AND THE ADAPTOR TAPER BY REPLACING THEM WITH THE SMR HUMERAL HEAD Ø42 MM (PRODUCT CODE 1322.09.420, LOT# 1516161 - STER. 1600030) AND THE NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT# 1512856 - STER. 1500344). THE CEMENTED GLENOID SMALL (PRODUCT CODE 1378.50.020, LOT# 1000948 - STER. 1000081) WAS NOT REPLACED. THE EVENT WAS REGISTERED AS COMPLAINT #161_2017 AND REPORTED TO THE FDA (MFR REPORT # 3008021110-2017-00053); · CONVERSION FROM A SMR ANATOMIC TOTAL TO SMR REVERSE PROSTHESIS PERFORMED ON (B)(6), 2020 DUE TO DISLOCATION AND PAIN (OBJECT OF THIS REPORT). DURING THIS SURGERY, THE SMR HUMERAL HEAD AND THE NEUTRAL ADAPTOR IMPLANTED ON (B)(6) 2017 WERE EXPLANTED AND EVEN THE CEMENTED GLENOID SMALL (PRODUCT CODE 1378.50.020, LOT# 1000948 - STER. 1000081) IMPLANTED ON (B)(6), 2011 WAS REPLACED SINCE, ACCORDING TO THE COMPLAINT SOURCE, THE ALL POLY GLENOID WAS ORIGINALLY IMPLANTED IN 15 DEGREES OF RETROVERSION RESULTING IN CONSTANT DISLOCATION AND PAIN. ACCORDING TO THE SURGEON RESPONSIBLE FOR THIS CONVERSION SURGERY (DIFFERENT FROM THE ONE RESPONSIBLE FOR THE FIRST REVISION SURGERY), THE ANATOMIC PROSTHESIS IMPLANTED FAILED FOR THE SECOND TIME SINCE THE GLENOID METAL BACK WAS NOT RECTIFIED DURING THE FIRST REVISION SURGERY. PATIENT IS FEMALE, 156CM, 72 KG. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT #1000948, #1516161, #1512856 AND #1010168 NO PRE-EXISTING ANOMALY WAS DETECTED ON ALL THE COMPONENTS MANUFACTURED WITH THESE LOT #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT NUMBERS. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO DISLOCATION AND PAIN PERFORMED ON (B)(6) 2020. THE ANATOMIC IMPLANT WAS CONVERTED TO REVERSE. THE EXPLANTED COMPONENTS ARE: CEMENTED GLENOID SMALL (PRODUCT CODE 1378.50.020, LOT# 1000948, STER. 1000081). SMR HUMERAL HEAD Ø42 MM (PRODUCT CODE 1322.09.420, LOT# 1516161, STER. 1600030). NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT# 1512856, STER. 1500344). SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT# 1010168, STER. 1100019) ACCORDING TO THE SOURCE, THE GLENOID WAS IMPLANTED IN 15 DEGREES OF RETROVERSION RESULTING IN CONSTANT DISLOCATION AND PAIN. FOR CONVERSION TO REVERSE, A TT METAL BACK, AN AXIOMA TT GLENOID PEG, A REVERSE HP LINER, A REVERSE HP GLENOSPHERE, A REVERSE HUMERAL BODY WITH LOCKING SCREW AND A SMALL-R CONNECTOR WITH SCREW WERE IMPLANTED. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2011. FIRST REVISION OF THE IMPLANT PERFORMED ON (B)(6) 2017: THE HUMERAL HEAD AND THE ADAPTOR TAPER IMPLANTED ON PRIMARY SURGERY WERE EXPLANTED DUE TO PAIN AND REPLACED BY THE SMR HUMERAL HEAD Ø42 MM (PRODUCT CODE 1322.09.420, LOT# 1516161, STER. 1600030) AND THE NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT# 1512856, STER. 1500344). THE EVENT WAS REGISTERED AS COMPLAINT #(B)(4) AND REPORTED TO THE TGA. THE PATIENT IS A FEMALE. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028050 CEMENTED GLENOID SMALL CEMENTED GLENOIDS SMALL KWT LIMACORPORATE S.P.A. 1378.50.020 1000948

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention