BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS REVISION STEM Ø13 MM

    MDR report key: 19641976 · Received July 1, 2024

    Report

    Report Number
    3008021110-2024-00059
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 14, 2024
    Report Date
    July 1, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    PMA / PMN Number
    K113523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF INVOLVED LOT # 1804452, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE (B)(4) DEVICES MANUFACTURED WITH THAT LOT #. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) REVISION STEMS WITH LOT #1804452 AND STER. 1800274 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. DEVICE ANALYSIS EXPLANTED DEVICES WEREN'T AVAILABLE TO BE RETURNED FOR ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY NO X-RAYS WERE AVAILABLE FOR ANALYSIS. STILL, IT WAS REPORTED BY THE COMPLAINT SOURCE THAT NO LOOSENING WAS VISIBLE ON THE PRE-OPERATIVE X-RAYS. MOREOVER, ACCORDING TO THE RECEIVED INFORMATION, THE SURGEON BELIEVES THAT THE BONE NOT GROWING ON THE IMPLANT IS DUE TO THE PATIENT'S COMORBIDITY. BASED ON THE RECEIVED INFORMATION, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. WE CANNOT DRAW A DEFINITIVE ROOT CAUSE FOR THE EVENT, HOWEVER STATING THAT: · CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON COMPONENTS MANUFACTURED WITH LOT #1804452; · ACCORDING TO THE RECEIVED INFORMATION, THERE WAS NO INFECTION AND THE REASON FOR THE STEM LOOSENING COULD LIE IN THE PATIENT'S COMORBIDITIES; WE CAN CONCLUDE THAT THE EVENT WASN'T PRODUCT RELATED. PMS DATA ACCORDING TO LIMA CORPORATE PMS DATA, THE REVISION RATE OF CEMENTLESS REVISION STEMS - BELONGING TO THE PRODUCT CODES 1308.15.XXX - DUE TO LOOSENING IS (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS ARE REQUIRED FOR THIS SPECIFIC CASE. LIMA CORPORATE CONTINUES MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2024, DUE TO PAIN. THE PATIENT WAS SCREENED FOR INFECTION, BUT RESULTS WERE NEGATIVE. THE ORIGINAL PLAN WAS TO POTENTIALLY CHANGE THE GLENOSPHERE, THE HUMERAL BODY AND THE LINER ONLY, DOING A WASH OUT. IT WAS REPORTED THAT UPON LINER REMOVAL, THE HUMERAL STEM CAME OUT. THE INSPECTION OF THE COMPONENTS REVEALED THAT THERE WAS ALMOST NO BONE ON GROWTH SUGGESTING THE HUMERAL STEM WAS LOOSE. THE FOLLOWING COMPONENTS WERE EXPLANTED: · SMR CEMENTLESS REVISION STEM Ø13 MM (PRODUCT CODE 1308.15.134, LOT #1804452 - STER. 1800274) · SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE 1352.15.050, LOT #1818730 - STER. 1900010) · SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1365.09.015, LOT #1815069 - STER. 1800340) - PRODUCT NOT SOLD IN THE US · SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #1818498 - STER. 1800400) · SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #1819691 - STER. 1900008) - PRODUCT NOT SOLD IN THE US. THE PATIENT WAS WASHED OUT AND AS THE ORIGINAL FRACTURE HAD HEALED A STANDARD UNCEMENTED STEM WAS IMPLANTED WITH THE SAME SIZED COMPONENTS REMOVED. THE PATIENT WAS THEN IRRIGATED AND CLOSED UP. PRIMARY SURGERY ON (B)(6) 2019. PATIENT IS A MALE, 71 YEARS OLD. HE HAS A BMI OF 28. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786447 SMR CEMENTLESS REVISION STEM Ø13 MM UNCEMENTED REVISION STEMS (TI6AL4V) DIA.13MM, H.150MM PHX LIMACORPORATE S.P.A. 1308.15.134 1804452

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention