BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-MAX S LATERALIZING UNCEMENTED STEMS

    MDR report key: 14602593 · Received June 6, 2022

    Report

    Report Number
    3008021110-2022-00044
    Event Type
    Injury
    Date Received
    June 6, 2022
    Date of Event
    November 5, 2021
    Report Date
    June 6, 2022
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    MEH
    PMA / PMN Number
    K160011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE 38 STEMS THAT BELONG TO LOT NUMBER 1911819 STER. 1900318. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER (1911819). A FINAL MDR WILL BE SUBMITTED AFTER THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE 38 STEMS THAT BELONG TO LOT NUMBER 1911819 STER. 1900318. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER (1911819). THE INVOLVED DEVICE WAS NOT RETURNED TO LIMACORPORATE, THEREFORE NO SPECIFIC ANALYSIS CAN BE PERFORMED ON IT. PRE AND POST-OPERATIVE X-RAYS (EXACT DATE NOT KNOWN) WERE RECEIVED BY LIMACORPORATE AND ANALYZED BY A MEDICAL CONSULTANT, HE COMMENTED THE FOLLOWING: "LOOSENING OF THE STEM IS OBVIOUS ON THE PRE-OP X-RAYS. IF SUCH AN IMPLANT BECOMES LOOSE AFTER ONLY ONE YEAR THERE ARE ONLY 3 OPTIONS AS THE REASON: 1. THERE WAS A LOW VIRULENT INFECTION, DETECTABLE ONLY BY SONICATION OF THE EXPLANT, OR 2. INCORRECT PLACEMENT OF THE STEM, OR 3. TOO SMALL SIZE OF THE STEM. I WOULD PRESUME A COMBINATION OF OPTION 2 AND 3. THE LATERAL VIEW SHOWS THE STEM INSERTED TOO MUCH ANTERIORLY, SUCH IMPINGING TOO EARLY WITH THE POSTERIOR CORTEX DISTALLY. SUCH PREPARATION CAME TO A STOP TOO EARLY, REQUIRING A TOO SMALL STEM. THIS MAY HAPPEN IN CASES WITH UNUSUAL ANATOMIC GEOMETRY (AS IN THE CASE) AND WHEN THE SURGERY IS DONE WITHOUT RADIOLOGICAL CONTROL. THE REVISION SHOWS REPLACEMENT USING THE SAME PATHWAY, HOWEVER IN A CEMENTED APPLICATION THIS SHOULD NOT BE AS DELETERIOUS AS IN AN UNCEMENTED ONE." IN SUMMARY: - THE ABSENCE OF PRE-EXISTING ANOMALY BY THE CHECK OF THE MANUFACTURING CHARTS OF THE LOT NUMBER INVOLVED, CONFIRMED THAT THE INVOLVED STEM WAS MANUFACTURED COMPLIANT TO DRAWING SPECIFICATIONS AND IN LINE WITH THE RELEVANT CHECK AND TESTS, - THE COMPLAINT SOURCE SUSPECTED THAT THE CAUSE OF THE REPORTED LOOSENING COULD BE RELATED TO THE SIZE OF THE STEM USED (TOO SMALL), - LIMACORPORATE'S MEDICAL CONSULTANT CONFIRMED THAT THE MOST PROBABLE CAUSE OF THE EVENT IS RELATED TO THE TOO SMALL SIZE OF THE STEM CHOSEN, COMBINED WITH ITS SUBOPTIMAL PLACEMENT. TO CONCLUDE, BASED UPON THE ANALYSES PERFORMED, THIS INCIDENT IS CLASSIFIED AS NOT PRODUCT RELATED; MOST PROBABLY, SURGICAL FACTORS CONTRIBUTED TO THE REPORTED IMPLANT LOOSENING AND CONSEQUENT REVISION SURGERY. PMS DATA BASED ON LIMACORPORATE PMS DATA, WE CAN ESTIMATE A REVISION RATE DUE TO LOOSENING OF THE H-MAX S STEMS (PRODUCT CODES 4251.20.XXX AND 4250.20.XXX) OF ABOUT 0.01%. NO CORRECTIVE ACTIONS NEEDED FOLLOWING THIS COMPLAINT. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO PAIN AND LOOSENING PERFORMED ON (B)(6) 2021. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2020. ACCORDING TO THE INFORMATION RECEIVED, THE FEMORAL STEM CHOSEN (H-MAX S LATERAL. FEM. STEM #8, CODE 4251.20.080, LOT 1911819, STER. 1900318) MIGHT HAVE BEEN TOO SMALL. EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO PAIN AND LOOSENING PERFORMED ON (B)(6)2021. DURING THE REVISION SURGERY, THE FEMORAL COMPONENTS (HEAD AND STEM) WERE REMOVED AND REPLACED WITH CEMENTED SYSTEM FROM A DIFFERENT MANUFACTURER. THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2020. THE COMPLAINT SOURCE DESCRIBED THE ISSUE AS RELATED TO ASEPTIC LOOSENING, NO INGROWTH ON THE STEM. THEY REPORTED NO SIGN OF INFECTION, SCALOPPING OF THE DIAFYSAIR CORTEX AND POSITIVE SCINTYGRAPHY AT 1 YEAR FOLLOW UP. ACCORDING TO THE INFORMATION RECEIVED, THE FEMORAL STEM IMPLANTED ON (B)(6)2020 (H-MAX S LATERAL. FEM. STEM #8, CODE 4251.20.080, LOT 1911819, STER. 1900318) WAS POSSIBLY TOO SMALL. THE OTHER COMPONENTS IMPLANTED IN MAY 2020 WERE THE FOLLOWING: - FEM. MODULAR HEAD - L Ø32MM, PRODUCT CODE 5010.42.323, LOT 1981126, STER. 1900410 - DELTA-PF ACETAB.CUP Ø54 MM PRODUCT CODE 5551.25.541, LOT 1916344, STER. 1900387 - DELTA PROTR.LINER ØINT 32MM #L PRODUCT CODE 5886.54.160, LOT 1907301, STER. 1900278 PATIENT DATA: 56 YEARS OLD, FEMALE, 70 KG, 167 CM. THIS EVENT OCCURRED IN NETHERLANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305319 H-MAX S LATERALIZING UNCEMENTED STEMS H-MAX S LATERALIZING UNCEMENTED STEMS MEH LIMACORPORATE SPA 4251.20.080 1911819

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention