BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOID BASEPLATE STANDARD

    MDR report key: 8526999 · Received April 18, 2019

    Report

    Report Number
    3008021110-2019-00051
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    April 10, 2019
    Report Date
    October 14, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K133349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF THE DHRS: BY CHECKING THE DHRS OF THE LOTS INVOLVED (#1801935, #1801936) NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 30 GLENOID BASEPLATES MANUFACTURED WITH LOT #1801935. NO OTHER COMPLAINTS WERE RECEIVED ON THIS LOT#. EXPLANT ANALYSIS: EXPLANTS WERE NOT AVAILABLE TO BE SENT TO LIMACORPORATE FOR ANALYSIS (DISPOSED OF AS PER HOSPITAL POLICY). X-RAY ANALYSIS: WE RECEIVED PRE-REVISION X-RAYS (EXACT DATE UNKNOWN) AND SENT THEM TO OUR CLINICAL CONSULTANT FOR A MEDICAL OPINION. HIS COMMENT IS REPORTED AS FOLLOW: "THE HUMERAL COMPONENT LOOKS CORRECT SIZE AND POSITION. THE OPERATIVE IMAGE SHOWS A CLASSIC SCAPULAR SPINE STRESS FRACTURE AT THE SPINO-GLENOID NOTCH WHICH IS USUALLY SIGNIFICANTLY SYMPTOMATIC AND DIFFICULT TO FIX. GENERICALLY THE CAUSES OF THESE STRESS FRACTURES ARE A COMBINATION OF IN NO ORDER OF IMPORTANCE: OSTEOPOROSIS, THE ABNORMAL STRESS PATTERNS ASSOCIATED WITH REVERSE ARTHROPLASTY, AND THE "TIGHTNESS OF THE ARTICULATION". I AM UNABLE TO IDENTIFY ANY SPECIFIC CAUSE OF THE FAILURES OTHER THAN THAT MENTIONED." BASED ON THE OPINION OF THE MEDICAL CONSULTANT WE CAN SPECULATE THAT PATIENT BONE CONDITION IS THE MAIN CAUSE OF LOOSENING OF THE PROSTHESIS, ALTHOUGH THE PROVIDED X-RAYS DID NOT ALLOW TO IDENTIFY A CLEAR CAUSE OF THE EVENT. IN ADDITION TO THE MEDICAL STATEMENT, COMPLAINT SOURCE REPORTED THE FOLLOWING COMMENT TO ASSIST OUR INVESTIGATION: "DESPITE THE FACT THAT THE TT METAL BACK GLENOID AND THE GLENOSPHERE WERE LOOSE, THERE DID NOT APPEAR TO BE ANY ISSUES WITH THE PROSTHESIS. ALL COMPONENTS WERE LOCKED TOGETHER WHERE TAPER JUNCTIONS WERE LOCATED AND REQUIRED DISASSEMBLING VIA THE INSTRUMENTS PER THE APPROPRIATE SURGICAL TECHNIQUES. THE SURGEON DID NOT BELIEVE THE SMR SYSTEM WAS RESPONSIBLE IN ANY WAY FOR THE FAILURE OF THE PREVIOUS OPERATION". IN CONCLUSION, STATING THAT: NO ANOMALY WAS DETECTED BY THE CHECK OF MANUFACTURING CHARTS AND THERE WERE NO FURTHER COMPLAINTS ASSOCIATED TO THE INVOLVED LOTS; X-RAY ANALYSIS CONFIRMED THE PRESENCE OF A HUMERAL FRACTURE, WHICH IS GENERALLY DUE TO COMBINATION OF OSTEOPOROSIS, ABNORMAL STRESS PATTERNS ASSOCIATED WITH REVERSE ARTHROPLASTY AND TIGHTNESS OF THE ARTICULATION; SURGEON RESPONSIBLE FOR SURGERY DID NOT SUSPECT ANY ISSUE RELATED TO THE IMPLANTS; AT THIS STAGE, WE ARE NOT ABLE TO IDENTIFY THE ROOT CAUSE OF THIS INCIDENT. HOWEVER, WE CAN SPECULATE THAT LOOSENING OF THE PROSTHESIS IS NOT PRODUCT-RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, WE ARE AWARE OF 6 COMPLAINTS DUE TO LOOSENING OF THE BASEPLATE BELONGING TO THE FAMILY OF CODE 1375.15.605/610/620 ON MORE THAN (B)(4) COMPONENTS SOLD WW SINCE 2014, WITH A REVISION RATE OF (B)(4). NO SPECIFIC CORRECTIVE ACTIONS FOR THIS CASE. LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET.

    Description of Event or Problem · 0

    CONVERSION SURGERY FROM SMR REVERSE TO HEMI WITH CTA HEAD PERFORMED ON THE OF (B)(6) 2019. CAUSE FOR CONVERSION WAS LOOSENING OF THE METAL BACK GLENOID (1375.15.610 LOT# 1801935) AND OF THE TT PEG (NOT MARKED IN USA) PREVIOUSLY IMPLANTED. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT UNDERWENT A PREVIOUS REVISION SURGERY DUE TO DISLOCATION ON THE (B)(6) 2018. (PREVIOUSLY REPORTED TO TGA: LIMA CORPORATE COMPLAINT# (B)(4), NOT REPORTED TO FDA). CAUSE FOR PREVIOUS REVISION SURGERY WAS TRACED TO INITIAL MALPOSITIONING OF THE METAL BACK GLENOID AND PATIENT'S BONE CONDITIONS. IT HAS BEEN REPORTED TO US THAT THIS PATIENT HAD DEVELOPED A NO TRAUMATIC SCAPULAR FRACTURE THAT, AT THE TIME OF PREVIOUS SURGERY ((B)(6) 2018), WAS NOT CORRECTLY DIAGNOSED AND REMAINED UNFIXED. THE LATEST REVISION REQUIRED REMOVAL OF ALL GLENOID COMPONENTS AND THE REVERSE LINER. THE COMPONENTS WERE REPLACED WITH A CTA HEAD AND ADAPTER AND ALLOWED TO ARTICULATE ON THE PATIENT'S NATIVE BONE. LARGE AMOUNTS OF ALLOGRAFT WERE POSTPONED IN PATIENT GLENOID BONE DEFECT. NO FURTHER INFORMATION REPORTED BY THE COMPLAINT SOURCE. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHRS OF THE LOT#S INVOLVED (1801935, 1801936) NO PRE-EXISTING ANOMALY WAS FOUND. NO OTHER COMPLAINTS RECEIVED ON THESE LOT #S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    CONVERSION SURGERY FROM SMR REVERSE TO HEMI WITH CTA PERFORMED ON (B)(6) 2019. CAUSE FOR REVISION WAS THE LOOSENING OF THE METAL BACK GLENOID (1375.15.610 LOT# 1801935) + TT PEG (1375.14.662 LOT# 1801936). ACCORDING TO THE INFO PROVIDED, THIS PATIENT UNDERWENT A PREVIOUS REVISION SURGERY DUE TO DISLOCATION ON (B)(6) 2018. THIS PATIENT HAD DEVELOPED A NON TRAUMATIC SCAPULAR FRACTURE THAT, AT THE TIME OF PREVIOUS SURGERY, WAS NOT CORRECTLY DIAGNOSED AND REMAINED UNFIXED. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320224 SMR GLENOID BASEPLATE STANDARD SMR GLENOID BASEPLATE STANDARD (KWS-KWT) KWS LIMACORPORATE SPA 1375.15.610 1801935

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention