BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY SHORT

    MDR report key: 8695563 · Received June 13, 2019

    Report

    Report Number
    3008021110-2019-00068
    Event Type
    Injury
    Date Received
    June 13, 2019
    Date of Event
    April 2, 2019
    Report Date
    July 18, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF THE DHR: BY CHECKING THE DHR OF THE LOTS INVOLVED, NO ANOMALY WAS FOUND: - ON A TOTAL OF (B)(4) HUMERAL BODIES MANUFACTURED WITH LOT #1201173; - ON A TOTAL OF (B)(4) LINERS MANUFACTURED WITH LOT #1202956. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. MOREOVER, ALL THE HUMERAL BODIES WITH LOT #1201173 HAVE BEEN ALREADY IMPLANTED WITHOUT RECEIVING ADDITIONAL COMPLAINTS. EXPLANTS ANALYSIS: EXPLANTS WERE NOT AVAILABLE TO BE SENT BACK TO LIMA CORPORATE FOR FURTHER INVESTIGATION. HOWEVER, WE RECEIVED PICTURES OF THE EXPLANTS AND, BY VISUAL ANALYSIS THE REVERSE HUMERAL BODY APPEARED TO BE SAW OFF ON THE INFERIOR PART AND THE PE LINER EXTREMELY WORN. X-RAYS ANALYSIS: WE RECEIVED X-RAYS REFERRING TO PRE-OP REVISION SURGERY (EXACT DATE UNKNOWN) AND SEND THEM TOGETHER WITH PICTURES OF THE EXPLANTS TO OUR MEDICAL CONSULTANT FOR A CLINICAL OPINION. HIS COMMENT IS FOLLOWING REPORTED: "THERE IS MAJOR WEAR ON ALL COMPONENTS. USUALLY THE EXPLANTED COMPONENTS DO NOT ADD MUCH TO THE EVALUATION BUT ON THIS OCCASION MOST DEFINITELY! WHAT WOULD BE INTERESTING WOULD BE A PICTURE OF THE EXPLANTED BASEPLATE? WERE THE 40 AND 44 MM ALL POLY GLENOSPHERES AVAILABLE AT THE TIME OF THE FIRST REVISION? EVEN IF THEY WEREN'T AND IT IS A MAJOR AND CHALLENGING EXERCISE TO GET A WELL FIXED BASEPLATE OUT, IT IS POSSIBLE AND SHOULD HAVE BEEN DONE.". ACCORDING TO OUR MEDICAL CONSULTANT, DURING PREVIOUS SURGERY THERE WAS A SUBOPTIMAL SURGICAL CHOICE OF THE IMPLANTS. THIS HYPOTHESIS IS SUPPORTED BY THE COMPLAINT SOURCE WHICH REPORTED THAT SURGEON RESPONSIBLE FOR REVISION SURGERY (DIFFERENT FROM THE ONE WHO PERFORMED THE PREVIOUS SURGERY) COMMENTED THAT IMPLANTING A 36MM ECCENTRIC GLENOSPHERE ON A STANDARD METAL BACK BASEPLATE DURING THE PREVIOUS SURGERY WAS NOT THE MOST APPROPRIATE CHOICE, CAUSING IMPINGEMENT AND LEADING TO THE CURRENT ISSUE. IN CONCLUSION, BASED ON THE CHECK OF THE DHRS AND ON THE OPINION OF OUR MEDICAL CONSULTANT + COMPLAINT SOURCE, WE CAN SPECULATE THAT THIS EVENT WAS MOSTLY RELATED TO SURGICAL FACTOR (SUBOPTIMAL CHOICE OF IMPLANTS PREVIOUSLY IMPLANTED). EVENT NOT PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, WE ARE NOT AWARE OF SIMILAR COMPLAINTS OR CASES OF BREAKAGE OF A REVERSE HUMERAL BODY COMPONENT. THIS IS THE FIRST AND ONLY CASE ON MORE THAN (B)(4) COMPONENTS SOLD WW SINCE 2002, THUS GIVING A REVISION RATE OF 0.001%. NO CORRECTIVE ACTIONS PLANNED FOR THIS CASE. LIMA CORPORATE WILL KEEP MONITORED THE MARKET.

    Description of Event or Problem · 0

    REVISION SURGERY OF A SMR REVERSE PROSTHESIS OCCURRED ON THE 2ND OF APRIL 2019 DUE TO BREAKAGE OF THE REVERSE HUMERAL BODY COD. 1352.15.005 LOT # 1201173. PRIMARY ANATOMIC SMR WAS PERFORMED ON (B)(6) 2010 THEN A CONVERSION TO REVERSE PROSTHESIS OCCURRED ON (B)(6) 2012. ACCORDING TO THE INFO REPORTED, DURING A ROUTINE VISIT THE PATIENT TOLD THE SURGEON THAT HIS LEFT SHOULDER WAS NOT THE BEST WITH LOSS OF RANGE OF MOTION. X-RAYS SHOWED THERE WAS PE WEAR IN THE LINER COD. 1360.50.020, LOT # 1202956 AND BONE LOSS OF THE GLENOID. ACCORDING TO THE INFO REPORTED, PATIENT HAS NOT HAD A PREVIOUS FALL, TRAUMA NOR SIGNS OF INFECTION. IT WAS REPORTED THAT PROBABLY, THE COMBINATION OF 36MM ECCENTRIC GLENOSPHERE WITH A STANDARD METAL BACK BASEPLATE IMPLANTED DURING THE PREVIOUS SURGERY WAS NOT THE MOST APPROPRIATE CHOICE. NO ADDITIONAL INFO RECEIVED BY THE COMPLAINT SOURCE. EVENT OCCURRED IN NEW ZEALAND.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT#S INVOLVED, NO ANOMALY WAS FOUND: ON A TOTAL OF (B)(4) HUMERAL BODIES MANUFACTURED WITH LOT #1201173; ON A TOTAL OF (B)(4) LINERS MANUFACTURED WITH LOT #1202956. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED WITH THESE LOT #S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY OCCURRED ON (B)(6) 2019 DUE TO BREAKAGE OF THE HUMERAL BODY COD. 1352.15.005 LOT # 1201173. PRIMARY ANATOMIC SMR WAS PERFORMED ON THE (B)(6) 2010, CONVERSION TO REVERSE OCCURRED ON (B)(6) 2012. ACCORDING TO THE INFO REPORTED, DURING THE VISIT THE PATIENT TOLD THE SURGEON THAT HIS LEFT SHOULDER WAS NOT THE BEST WITH LOSS OF RANGE OF MOTION. XR SHOWED THERE WAS PE WEAR IN THE LINER COD. 1360.50.020, LOT # 1202956 AND BONE LOSS ON THE GLENOID. THE PATIENT HAS NOT HAD A PREVIOUS FALL, TRAUMA NOR SIGNS OF INFECTION. IT WAS REPORTED THAT PROBABLY, THE COMBINATION OF 36 ECC GLENOSPHERE WITH STANDARD BASEPLATE IN PREVIOUS SURGERY WAS NOT THE RIGHT CHOICE. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488344 SMR REVERSE HUMERAL BODY SHORT SMR REVERSE HUMERAL BODY SHORT KWS LIMACORPORATE SPA 1352.15.005 1201173

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention