BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY SHORT

    MDR report key: 14009059 · Received April 5, 2022

    Report

    Report Number
    3008021110-2022-00021
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    March 17, 2022
    Report Date
    August 4, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2114391, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 62 ITEMS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 45 OUT OF 62 HUMERAL BODIES WITH LOT #2114391 - STER. 2100245 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2012810, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 20 ITEMS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 9 OUT OF 20 LINERS WITH LOT #2012810 - STER. 2000317 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. EXPLANTS ANALYSIS. THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS. LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAYS RECEIVED - EXACT DATE NOT KNOWN - HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE RADIOGRAPHS SHOW THE DISLOCATED HUMERUS AND CERCLAGES AS A RESULT OF PREVIOUS SURGERY FOR REVISION. THE METAPHYSIS OF THE HUMERUS SHOWS A BONE DEFICIT (RESORPTION OF THE TUBEROSITIES), WHICH IS FREQUENTLY FOUND IN REVISION CASES OR POST-TRAUMATIC CASES ETC. THIS CAN ATTRIBUTE TO INSTABILITY ADDITIONALLY TO THE SOFT TISSUE PROBLEMS IN MULTIPLE REVISION FOR INSTABILITY. THE IMPLANTS ITSELF LOOK UNREMARKABLE, THERE IS NO EVIDENCE FOR AN IMPLANT-RELATED ISSUE HERE. THIS IS EITHER FATEFUL OR PATIENT/DISEASE/SURGICAL PROCEDURE RELATED, BUT THIS ALL NOT CLEAR EX POST". CONSIDERING THAT: CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOTS #2114391 AND #2012810; ACCORDING TO THE COMPLAINT SOURCE, THE PATIENT HAS HAD ONGOING INSTABILITY SINCE PREVIOUS REVISION; ACCORDING TO THE MEDICAL CONSULTANT "THE METAPHYSIS OF THE HUMERUS SHOWS A BONE DEFICIT (RESORPTION OF THE TUBEROSITIES), WHICH IS FREQUENTLY FOUND IN REVISION CASES OR POST-TRAUMATIC CASES ETC. THIS CAN ATTRIBUTE TO INSTABILITY ADDITIONALLY TO THE SOFT TISSUE PROBLEMS IN MULTIPLE REVISION FOR INSTABILITY. THE IMPLANTS ITSELF LOOK UNREMARKABLE, THERE IS NO EVIDENCE FOR AN IMPLANT-RELATED ISSUE HERE"; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA. ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO DISLOCATION IS 0.15%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Additional Manufacturer Narrative · 0

    CHECKING THE DHR OF THE INVOLVED LOTS #2114391 AND #2012810, NO ANOMALIES WERE FOUND ON THE ITEMS MANUFACTURED WITH THESE LOT #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THOSE LOT #S. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2022, DUE TO IMPLANT DISLOCATION. IT WAS REPORTED THAT THE HUMERAL VERSION WAS CHANGED TO AROUND 10 DEGREES OF ANTIVERSION IN ORDER TO REDUCE THE RISK OF DISLOCATION OUT THE FRONT. THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #2114391 - STER. 2100245). SMR REVERSE HP LATERALIZING LINER LONG (PRODUCT CODE 1362.09.120, LOT #2012810 - STER. 2000317) - PRODUCT NOT SOLD IN THE US ACCORDING TO THE COMPLAINT SOURCE, THE PATIENT HAS HAD ONGOING INSTABILITY SINCE PREVIOUS REVISION. PATIENT'S CLINICAL HISTORY OF SHOULDER REVISION SURGERIES IS THE FOLLOWING: PRIMARY SURGERY TOOK PLACE ON MAY 7TH, 2015. A SMR ANATOMIC TOTAL PROSTHESIS WAS IMPLANTED; FIRST REVISION SURGERY TOOK PLACE ON (B)(6) 2021, DUE TO CUFF FAILURE. THE EVENT WAS REGISTERED AS COMPLAINT (B)(4). SECOND REVISION SURGERY TOOK PLACE ON (B)(6) 2021, DUE TO IMPLANT DISLOCATION. PATIENT WAS WITHOUT HIS ARM IN HIS SLING. THE EVENT WAS REGISTERED AS COMPLAINT (B)(4). THIRD REVISION SURGERY TOOK PLACE ON (B)(6) 2022, DUE TO IMPLANT DISLOCATION (HEREBY REPORTED). IT WAS REPORTED THAT DUE TO HIS HISTORY OF INSTABILITY, THE PATIENT WAS PLACED IN AN ABDUCTION SLING FOR 6 WEEKS. PATIENT IS A MALE, 75 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2022, DUE TO IMPLANT DISLOCATION. IT WAS REPORTED THAT THE HUMERAL VERSION WAS CHANGED TO AROUND 10 DEGREES OF ANTIVERSION IN ORDER TO REDUCE THE RISK OF DISLOCATION OUT THE FRONT. THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #2114391 - STER. 2100245). SMR REVERSE HP LATERALIZING LINER LONG (PRODUCT CODE 1362.09.120, LOT #2012810 - STER. 2000317). ACCORDING TO THE COMPLAINT SOURCE, THE PATIENT HAS HAD ONGOING INSTABILITY SINCE PREVIOUS REVISION. PATIENT'S CLINICAL HISTORY OF SHOULDER REVISION SURGERIES IS THE FOLLOWING: PRIMARY SURGERY TOOK PLACE ON (B)(6) 2015. A SMR ANATOMIC TOTAL PROSTHESIS WAS IMPLANTED; FIRST REVISION SURGERY TOOK PLACE ON (B)(6) 2021, DUE TO CUFF FAILURE. THE EVENT WAS REGISTERED AS COMPLAINT #(B)(4); SECOND REVISION SURGERY TOOK PLACE ON (B)(6) 2021, DUE TO IMPLANT DISLOCATION. PATIENT WAS WITHOUT HIS ARM IN HIS SLING. THE EVENT WAS REGISTERED AS COMPLAINT #(B)(4); THIRD REVISION SURGERY TOOK PLACE ON (B)(6) 2022, DUE TO IMPLANT DISLOCATION (HEREBY REPORTED). IT WAS REPORTED THAT DUE TO HIS HISTORY OF INSTABILITY, THE PATIENT WAS PLACED IN AN ABDUCTION SLING FOR 6 WEEKS. PATIENT IS A MALE, (B)(6). EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79015 SMR REVERSE HUMERAL BODY SHORT SHORT REVERSE HUMERAL BODY (INVERSION ONLY) KWS LIMACORPORATE S.P.A. 1352.15.005 2114391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention