BEUDAMED
    FDA Adverse Event Death Summary report: N

    RSP SHOULDER

    MDR report key: 2735456 · Received September 5, 2012

    Report

    Report Number
    1644408-2012-00485
    Event Type
    Death
    Date Received
    September 5, 2012
    Date of Event
    August 30, 2012
    Report Date
    August 30, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL INCIDENT REPORTED WAS DURING TRIAL REDUCTION, THE SURGEON COULD NOT RETRACT SOFT TISSUE TO GET A GOOD TRIAL. AT SOME POINT, BLOOD BEGAN TO COME FROM THE JOINT. THE SURGEON REQUESTED THE COMPONENTS BE OPENED BASED ON THE LAST PLACED SIZES, WHILE THE SURGEON ADDRESSED THE BLEEDING ISSUE. THE PATIENT NEVER RECOVERED FROM THE BLEEDING AND DIED. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE DEATH OF THE PATIENT. THE HEALTHCARE PROFESSIONAL INDICATED A SERIOUS RISK TO THE PATIENT. THERE WAS NO PATIENT DATA PROVIDED FOR REVIEW OTHER THAN AGE AND SEX. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS NOT AVAILABLE FOR USE. THE REVISION SURGERY WAS NOT COMPLETED AS INTENDED. THE REPRESENTATIVE WAS ASKED TO LEAVE THE ROOM. THE DEVICES WERE RETURNED TO DJO SURGICAL FOR EXAMINATION. THE SURGICAL IMPLANTS WERE OPENED, BUT NEVER PLACED IN-VIVO. THE REVERSE SHOULDER PROSTHESIS (RSP) INSTRUMENTS USED WERE INSPECTED WITH A 5X MAGNIFIER. THE SURFACE FINISHES OF ALL THE DEVICES SHOWED EVIDENCE OF SMALL NICKS, DINGS, AND SCRATCHES FROM USE, BUT NO SIGNIFICANT WEAR THAT WOULD INTERFERE WITH DEVICE FUNCTION. THE SOCKET SHELL TRIAL INSERT, MADE OF POLYPHENYLSULFONE (RADEL), HAD AN UNUSUALLY LARGE NUMBER OF WEAR MARKS IN THE CONCAVE SECTION FOR BEING 13 MONTHS OLD, BUT THE USAGE RATE OF THE DEVICE IS UNKNOWN. A FIT CHECK WAS PERFORMED OF THE SOCKET SHELL TRIAL INSERT IN THE SOCKET SHELL TRIAL AND THE TWO DEVICES HAD A GOOD CONNECTION DURING BOTH ASSEMBLY AND DISASSEMBLY. ALL OF THE DEVICES WERE MEASURED AND WERE WITHIN SPECIFICATION. THE DEVICE HISTORY RECORDS WERE EXAMINED AND THERE WAS ONE NON-CONFORMING MATERIAL REPORT FOR ONE OF THE LOTS, NCMR 17469, FOR THE SOCKET SHELL INSERT TRIAL. THERE WERE DIMENSIONAL AND MARKING DISCREPANCIES AFFECTING SIX OF THE TWENTY FIVE ITEMS IN THAT LOT. ALL NON-CONFORMING ITEMS WERE RETURNED TO THE VENDOR AND DID NOT PLAY A ROLE IN THIS PRODUCT COMPLAINT. ALL RELEASED INSTRUMENTS FULLY MET QUALITY CONTROL SPECIFICATIONS. FIVE OF THESE SIX PRODUCTS HAD MORSE TAPER FITS. ALL FIVE OF THE AFFECTED LOTS PASSED QUALITY CONTROL INSPECTION ON 100% OF THE MORSE TAPER FITTINGS. A RISK ANALYSIS WAS PERFORMED ON THE RSP MONOBLOCK IMPLANT AND INSTRUMENT DEVICES AND IT SHOWED THESE PRODUCTS MET SAFETY CRITERIA. (B)(4). THE PRIOR PRODUCT COMPLAINT REPORTS WERE EXAMINED. NO OTHER COMPLAINTS FOR REDUCTION PROBLEMS FOR THE RSP MONOBLOCK SYSTEM WERE LOCATED DEALING INITIALLY WITH TRIALS; HOWEVER, THERE WERE FOUR COMPLAINTS FOR MISMATCHES BETWEEN THE RSP SYSTEM AND IMPLANTS REFERENCED IN COMPLAINT NUMBERS: (B)(4). THE ROOT CAUSE FOR THIS INVESTIGATION COVERS THE DEATH OF THE PATIENT FROM BLOOD LOSS DURING AN INITIAL INSTALLATION OF A REVERSE SHOULDER PROSTHESIS (RSP) MONOBLOCK SYSTEM. A REVIEW OF THE DJO SURGICAL REPORT, INSPECTION OF ALL SIX RETURNED INSTRUMENTS, THE EXAMINATION OF THE DEVICE HISTORY RECORDS, AND A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED ALL THE RSP DEVICES MET MATERIAL, DESIGN, AND MANUFACTURING REQUIREMENTS. THE DEATH WAS NOT RELATED TO DEFECTS IN THE SURGICAL INSTRUMENTS OR IMPLANTS. OTHER SURGICAL OR HEALTH FACTORS LED TO THE LOSS OF LIFE. NO PATIENT DATA WAS PROVIDED FOR REVIEW. A DETAILED REPORT ON THE OPERATION WAS NOT AVAILABLE FOR DJO SURGICAL EXAMINATION.

    Description of Event or Problem · 1

    PRIMARY SURGERY - DURING TRIAL REDUCTION, THE SURGEON COULD NOT RETRACT SOFT TISSUE TO GET A GOOD TRIAL. AT SOME POINT, BLOOD STARTED TO COME FROM THE JOINT. THE SURGEON REQUESTED THE COMPONENTS BE OPENED BASED ON THE LAST PLACED SIZES, WHILE SURGEON ADDRESSED THE BLEEDING ISSUE. THE PATIENT NEVER RECOVERED FROM THE BLEEDING AND DIED. THE INSTRUMENTS WERE TRIALED AS FOLLOWS: THE SIZE 12 HUMERAL BROACH WAS STILL IN THE HUMERUS WHILE TRIALING THE 32MM NEUTRAL SOCKET TRIAL INSERTED WITH A 32 ID STANDARD LINER, REALIZED THE 32MM NEUTRAL STANDARD GLENOID HEAD TRIAL WAS TOO TIGHT AND DID A REDUCTION TO A 32MM -4 GLENOID HEAD TRIAL. THE IMPLANTS WERE OPENED BUT WERE NEVER PLACED IN-VIVO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER HUMERAL SOCKET SHELL TRIAL KWS ENCORE MEDICAL, L.P. 36887L05B

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death 804-03-043, LOT 35538L14| 804-02-468, LOT UNK| 804-03-042, LOT 36887L08| 804-02-043, LOT UNK| 804-02-468, LOT 53232L01| 804-02-016, LOT UNK| 804-02-017, LOT 37694L15| 804-02-016, LOT 37694L14| 804-02-017, LOT UNK