BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CTA HUMERAL HEAD (COCRMO) DIA.46MM

    MDR report key: 8909994 · Received August 20, 2019

    Report

    Report Number
    3008021110-2019-00092
    Event Type
    Injury
    Date Received
    August 20, 2019
    Date of Event
    August 9, 2019
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    PMA / PMN Number
    K110847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHRS CHECK: BY CHECKING THE MANUFACTURING CHARTS OF THE LOT#: INVOLVED (1003323) NO PRE-EXISTING ANOMALY WAS FOUND ON THE (B)(4) COMPONENTS PLACED ON THE MARKET WITH THE SAME LOT#. EXPLANTS ANALYSIS: EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR ANALYSIS. XRAYS ANALYSIS: WE RECEIVED XRAY IMAGES TAKEN ON UNKNOWN DATE AND FORWARDED THEM TO OUR MEDICAL CONSULTANT FOR A CLINICAL EVALUATION. HIS COMMENTS AS PER FOLLOWS: "WHAT WE CAN SEE FROM VERY POOR REPRODUCTION OF RADIO-GRAPHS IS PROBABLY A WELL POSITIONED HEMIARTHROPLASTY (CTA HEAD) WHICH IS ARTICULATING WITH THE ACROMIUM. THE POSITION SEEMS APPROPRIATE AND I CANNOT SEE ANY OBVIOUS ARE FOR CONCERN BUT MY FIRST COMMENT THAT THESE ARE VERY POOR REPRODUCTIONS APPLIES. WE KNOW FROM EXPERIENCE THAT HEMIARTHROPLASTY DOES NOT HAVE A GOOD OUTCOME IN CUFF TEAR FAILURE AND LIKELY THEREFORE THE REASON FOR REVISION. IT IS REGRETTABLE THAT REVERSE WAS NOT CARRIED OUT IN THE FIRST INSTANCE ALTHOUGH I COMPLETELY UNDERSTAND THE SURGEONS POINT OF VIEW." CONCLUSION: BASED ON OUR ANALYSIS, THE REASON FOR THIS REVISION DOES NOT SEEM TO BE RELATED TO THE PRODUCT ITSELF: THE CHECK OF THE DHRS CONFIRMED THAT THE CTA HEAD HAD BEEN MANUFACTURED UP TO SPECIFICATIONS, NO DEVIATION DETECTED. OUR MEDICAL CONSULTANT SUGGESTED THAT THE IMPLANTATION OF A SMR REVERSE PROSTHESIS DURING PRIMARY SURGERY COULD HAVE HAD A BETTER OUTCOME. NEVERTHELESS, AS REPORTED BY THE COMPLAINT SOURCE, SMR REVERSE WAS NOT IMPLANTED DURING PREVIOUS SURGERY DUE TO THE CONDITION OF THE PATIENT AT THAT TIME. IN CONCLUSION, WE CANNOT GO BACK WITH CERTAINTY TO THE ROOT CAUSE OF THE CUFF FAILURE REPORTED, HOWEVER, AT THIS STAGE, THIS EVENT CANNOT BE CLASSIFIED AS PRODUCT-RELATED. PMS DATA: (B)(4). NO SPECIFIC ACTION FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY OF SMR ANATOMIC HEMI PROSTHESIS (WITH CTA HEAD CODE: 1323.09.460, LOT#: 1003323) PERFORMED ON (B)(6) 2019. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2015. ACCORDING TO THE INFO REPORTED, THE CAUSE OF THE REVISION WAS RELATED TO CUFF TEAR ARTHROPATHY AND SUPERIOR MIGRATION OF THE HUMERAL COMPONENTS WITH SUBSEQUENT ARTICULATION WITH THE ACROMION. CONSEQUENT PATIENT'S PAIN AND LIMITED RANGE OF MOTION WERE REPORTED. DURING REVISION SURGERY, A SMR REVERSE PROSTHESIS WAS IMPLANTED. ACCORDING TO THE INFO RECEIVED, THE SMR REVERSE PROSTHESIS WAS NOT IMPLANTED DURING PREVIOUS SURGERY BECAUSE THE PATIENT HAD A PREVIOUS GUN SHOT WOUND TO THE REGION AND THE HEALTH OF THE DELTOID WAS POOR. REHAB EXERCISES HAVE SINCE BEEN COMPLETED AND THE SURGEON DEEMED THE DELTOID AS HEALTHY ENOUGH TO SUPPORT A REVERSE SMR. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHARTS OF THE LOT# INVOLVED (1003323) NO PRE-EXISTING ANOMALY WAS FOUND ON THE 40 COMPONENTS PLACED ON THE MARKET WITH THE SAME LOT#. WE WILL PROCEED WITH FURTHER INVESTIGATIONS AND SUBMIT A FINAL MDR ONCE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY OF SMR ANATOMIC HEMI PROSTHESIS (WITH CTA HEAD CODE (B)(4), LOT# 1003323) DUE TO CUFF FAILURE, PERFORMED ON (B)(6) 2019. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2015. DURING REVISION SURGERY A SMR REVERSE PROSTHESIS WAS IMPLANTED. ACCORDING TO THE INFO RECEIVED, THE SMR REVERSE WAS NOT IMPLANTED DURING PREVIOUS SURGERY BECAUSE THE PATIENT HAD A PREVIOUS GUN SHOT WOUND TO THE REGION AND THE HEALTH OF THE DELTOID WAS POOR. REHAB EXERCISES HAVE SINCE BEEN COMPLETED AND THE SURGEON DEEMED THE DELTOID AS HEALTHY ENOUGH TO SUPPORT A REVERSE SMR. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705340 CTA HUMERAL HEAD (COCRMO) DIA.46MM CTA HUMERAL HEAD (COCRMO) DIA.46MM HSD LIMACORPORATE S.P.A. 1323.09.460 1003323

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention