BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVISION MODULAR STEM Ø16MM

    MDR report key: 8801573 · Received July 18, 2019

    Report

    Report Number
    3008021110-2019-00082
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    July 5, 2019
    Report Date
    January 4, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K151739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1814024, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) WITH LOT #1814024 AND STER. 1800298 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. EXPLANTS ANALYSIS: EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED ONE X-RAY REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAY RECEIVED - EXACT DATE NOT KNOWN - HAS BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE X-RAY THAT YOU NAMED "PRE-OP" DOES NOT SHOW ANY REASON FOR A REVISION. INDEED THERE IS A FRACTURE VISIBLE SUBTROCHANTERICALLY, SEEMINGLY CAUSED BY SOME SEVERE OSTEOLYSIS IN THE REGION OF THE PROXIMAL FEMUR. I PRESUME THERE HAS BEEN SOME LOOSENING OF A PRIMARY HIP BEFORE, LEADING TO OSTEOLYSIS AND CONSEQUENT FRACTURE AT ITS TIP. HOWEVER, THE SENT X-RAY SHOWS A PERFECT RECONSTRUCTION WITH A WELL PLACED REVISION STEM OF PERFECT DIMENSIONS, BRIDGING THE FRACTURE SUFFICIENTLY. I DO NOT UNDERSTAND THE RATIONALE BEHIND DOING ANOTHER REVISION WITH A STEM ONLY 2MM THICKER AND A NECK 10MM SHORTER". CONSIDERING THAT: · CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT #1814024; · THE SUBSIDENCE OF THE STEM WAS NOT CONFIRMED BY THE MEDICAL CONSULTANT. ACCORDING TO HIS OPINION "THE SENT X-RAY SHOWS A PERFECT RECONSTRUCTION WITH A WELL PLACED REVISION STEM OF PERFECT DIMENSIONS, BRIDGING THE FRACTURE SUFFICIENTLY. I DO NOT UNDERSTAND THE RATIONALE BEHIND DOING ANOTHER REVISION WITH A STEM ONLY 2MM THICKER AND A NECK 10MM SHORTER"; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF REVISION STEMS - BELONGING TO THE FAMILY CODES 38XX.15.0X0 - DUE TO SUBSIDENCE IS (B)(4). 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.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE OCCURRED ON (B)(6), 2019. PRIMARY SURGERY WAS PERFORMED ON (B)(6), 2019. ACCORDING TO THE INFO REPORTED, THE REVISION STEM (PRODUCT CODE 3812.15.010, LOT #1814024) SUBSIDED LEADING TO FRACTURE. SURGEON COMMENTED THAT SUBSIDENCE COULD HAVE BEEN DUE TO THE POSSIBLE UNDERSIZED STEM. THE PATIENT DID NOT REPORT ANY TRAUMATIC EVENT. THE FOLLOWING COMPONENTS WERE REMOVED: · REVISION MODULAR STEM Ø16MM (PRODUCT CODE 3812.15.010, LOT #1814024 - STER. 1800298). · FEMORAL MODULAR HEAD - L Ø32MM (PRODUCT CODE 5010.09.323, LOT #1811385 - STER. 1800324). · REVISION MODULAR NECK H.90MM (PRODUCT CODE 7515.15.040, LOT #1817929 - STER. 1800399). DURING THE REVISION, THE EXPLANTED STEM (16X140) AND NECK (90MM) WERE REPLACED BY STEM 18X140 AND NECK 80 MM. PATIENT IS A FEMALE. EVENT OCCURRED IN NEW ZEALAND.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT #1814024 NO ANOMALY WAS FOUND ON A TOTAL OF (B)(4) STEMS MANUFACTURED WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED WITH THIS LOT#. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE OCCURRED ON (B)(6) 2019. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. ACCORDING TO THE INFO REPORTED, THE REVISION STEM CODE (B)(4), LOT #1814024 SUBSIDED LEADING TO FRACTURE. SURGEON COMMENTED THAT SUBSIDENCE COULD HAVE BEEN DUE TO POSSIBLE UNDERSIZED OF THE STEM. THE PATIENT DID NOT REPORT ANY TRAUMATIC EVENT. DURING REVISION SURGERY STEM (16X140) + NECK (90MM) WERE REMOVED AND STEM 18X140 + NECK 80 MM HAVE BEEN IMPLANTED. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595835 REVISION MODULAR STEM Ø16MM REVISION STEM DIA. 16 MM, L. 140 MM LZO LIMACORPORATE S.P.A. 3812.15.010 1814024

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention