BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 21967669 · Received May 6, 2025

    Report

    Report Number
    3008021110-2025-00045
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    April 1, 2025
    Report Date
    April 23, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    UDI-DI
    08033390085014
    PMA / PMN Number
    K142139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS INVOLVED IN THE EVENT, NO PRE-EXISTING ANOMALY WAS FOUND IN THE ITEMS BELONGING TO THE SAME PRODUCT CODES AND LOT NUMBERS AS THE DEVICES REMOVED DURING THE REVISION SURGERY. THE MANUFACTURER WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #20BN00X, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 20 INSTRUMENTS MANUFACTURED WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #14HM069, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 50 INSTRUMENTS MANUFACTURED WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. DEVICE ANALYSIS: THE DEVICES INVOLVED IN THE COMPLAINT WEREN'T RETURNED FOR ANALYSIS. LIMACORPORATE RECEIVED SOME COMPLAINTS REPORTING INTRA-OPERATIVE DIFFICULTIES IN DISASSEMBLING TRIAL NECKS FROM RASPS, AND THE DOUBT THAT THE TRIAL COMPONENTS PROPERLY REPRODUCE THE DEFINITIVE IMPLANT. THE ANALYSIS OF PAST COMPLAINTS HIGHLIGHTED THAT THERE'S NO DESIGN ISSUE WITH THE MINIMA TRIAL COMPONENTS AS THE RETURNED DEVICES WERE FOUND TO BE WITHIN THE DESIGN TOLERANCES. REGARDING THE DIFFICULTIES IN DISASSEMBLING TRIAL NECKS FROM RASPS, IT SHOULD BE CONSIDERED THAT THE COUPLING BETWEEN TRIAL NECKS AND BROACHES IS BY MEANS OF CONIC COUPLING. ACCORDING TO THE APPLICABLE SURGICAL TECHNIQUE, THE TRIAL NECK IS PLACED IN THE BROACH USING THE NECK BEATER (PRODUCT CODE 9042.15.230). THE CONIC COUPLING BETWEEN DEVICES ALLOWS TO HAVE A STABLE COUPLING OF THE TRIAL ASSEMBLY, BUT GIVEN THAT IT IS CONIC, THE MORSE TAPERING BETWEEN COMPONENTS CAN OCCUR. AFTER COMPLETING THE TRIALLING PHASE AND WHEN THE FOUND TRIAL CONFIGURATION MATCHES THE DESIRED PARAMETERS OF BIOMECHANICS OF THE IMPLANT, THE TRIAL NECK IS REMOVED FROM THE BROACH USING THE NECK EXTRACTOR. ALTERNATIVELY, ANY SUITABLE INSTRUMENT TO PLACE IN THE TRIAL NECK'S HOLE CAN BE USED TO LEVERAGE AND THUS REMOVE THE TRIAL NECK. FURTHERMORE, AFTER IMPLANTING THE DEFINITIVE MINIMA STEM IN THE FEMUR, THE LENGTH OF THE HEAD PREVIOUSLY DETERMINED CAN BE RECHECKED INTO THE DEFINITIVE STEM USING THE TRIAL HEADS. REGARDING THE DOUBT THAT THE TRIAL COMPONENTS PROPERLY REPRODUCE THE DEFINITIVE IMPLANT, A COMPARATIVE ANALYSIS BETWEEN THE TRIAL ASSEMBLY AND THE DEFINITIVE IMPLANT HAS BEEN PERFORMED CONSIDERING THE TOLERANCES SET OUT IN DEVICES DESIGNS, AND IT WAS PROVEN THAT NO SIGNIFICANT DEVIATION OF THE MINIMA TRIAL ASSEMBLY FROM THE DEFINITIVE IMPLANT IS EXPECTED. INDEED, THE CHAIN OF TOLERANCES OF THE BROACH AND OF THE TRIAL NECK ARE ALWAYS INTO THE RANGE THAT THE DEFINITIVE IMPLANT ALLOWS TO ACCOMMODATE. THE TOLERANCES APPLIED TO THE DIMENSIONS HAVE THE AIM TO ESTABLISH THE BOUNDARIES OF THIS VARIABILITY, TO KEEP ALWAYS THE COMPONENTS ALIGNED WITH THE PROJECT REQUIREMENTS. DEVICES ARE RELEASED ON THE MARKET ONLY AFTER DIMENSIONAL INSPECTIONS IN WHICH THE COMPLIANCE WITH THE SPECIFICATIONS DEFINED IN THE DRAWINGS IS CONFIRMED. MOREOVER, IT WAS REPORTED BY THE COMPLAINT SOURCE THAT THE MINIMA FEMORAL SYSTEM WAS COUPLED WITH ACETABULAR COMPONENTS OF A COMPETITOR SYSTEM. ACCORDING TO THE APPLICABLE IFUS (INSTRUCTIONS FOR USE), "WHEN USED IN TOTAL HIP ARTHROPLASTY, MONOLITHIC CEMENTLESS STEMS ARE INTENDED FOR USE WITH MODULAR HEADS AND COMPATIBLE ACETABULAR CUPS" AND "LIMACORPORATE MONOLITHIC CEMENTLESS STEMS MUST NOT BE USED WITH COMPONENTS FROM OTHER SYSTEMS OR OTHER MANUFACTURERS". A LIST OF EXEMPTIONS IS PROVIDED, AND THE SPECIFIC COMPETITOR'S ACETABULAR SYSTEM IS NOT FOUND AMONG THEM. CONSIDERING THAT: · CHECK OF DHRS HIGHLIGHTED NO ANOMALIES ON COMPONENTS MANUFACTURED WITH LOTS #20BN00X AND #14HM069; · ANALYSIS ON SIMILAR COMPLAINTS REVEALED THAT THERE'S NO DEVIATION OF THE MINIMA TRIAL ASSEMBLY FROM THE DEFINITIVE IMPLANT; · ACCORDING TO THE RECEIVED INFORMATION, THE MINIMA SYSTEM WAS COUPLED TO A COMPETITOR'S ACETABULAR COMPONENTS: THE COUPLING HAS NOT BEEN TESTED, THEREFORE IT IS NOT ALLOWED; WE CAN'T CONFIRM THE REPORTED ISSUE, AND WE CAN'T DRAW A DEFINITIVE ROOT CAUSE FOR THE EVENT. STILL, WE CAN STATE THAT IT IS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, THE OCCURRENCE RATE OF INTRA-OPERATIVE DIFFICULTIES IN DISASSEMBLING MINIMA TRIAL NECKS (PRODUCT CODES (B)(4)) FROM RASPS, AND THE DOUBT THAT THE MINIMA TRIAL COMPONENTS PROPERLY REPRODUCE THE DEFINITIVE IMPLANT IS ESTIMATED TO BE (B)(4) (WW). PLEASE NOTE THAT THIS OCCURRENCE RATE IS OVERESTIMATED BECAUSE IT DOES NOT CONSIDER THE REUSE OF THE INSTRUMENTS BUT ONLY THE TOTAL NUMBER OF PIECES MANUFACTURED. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS ARE REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE 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 WAS PERFORMED ON (B)(6) 2025, DUE TO IMPLANT DISLOCATION. THE PATIENT HAD PREVIOUS REVERSE SHOULDER SURGERY ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT DISLOCATED SOMETIME AFTER, AND THE DOCTOR DECIDED TO REVISE THE MODULAR PARTS TO HELP PREVENT POSSIBLE FUTURE DISLOCATION. THE FOLLOWING COMPONENTS WERE REMOVED: - SMR REVERSE LINER STD D.40MM (PART CODE 1365.50.810, LOT NUMBER 23AT07N, STERILIZATION (B)(4)). - SMR CONNECTOR SMALL STD (PART CODE 1374.15.310, LOT NUMBER 2418873, STERILIZATION (B)(4)). - SMR ECCENT. GLENOSPHERE DIA. 40MM (PART CODE 1376.09.041, LOT NUMBER 2433287, STERILIZATION (B)(4)). THE ABOVE-MENTIONED COMPONENTS WERE REPLACED BY THE FOLLOWING NEW ONES: - SMR CONNECTOR SMALL STD +4MM (PART CODE 1374.15.324, LOT NUMBER 2202384, STERILIZATION (B)(4)). - SMR REVERSE LINER RET. +3 MM (PART CODE 1365.50.816, LOT NUMBER 23AT1TE, STERILIZATION (B)(4)). - SMR ECCENT. GLENOSPHERE DIA. 40MM (PART CODE 1376.09.041, LOT NUMBER 2314910, STERILIZATION (B)(4)). THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1963. THE EVENT HAPPENED IN THE UNITED STATES.

    Description of Event or Problem · 0

    THE SURGERY WAS COMPLETED BY IMPLANTING: - MINIMA S LAT #5 (PRODUCT CODE 4504.21.050, LOT #2327723 - STER. (B)(4)). - FEMORAL MODULAR HEAD M Ø32MM (PRODUCT CODE 5010.42.322, LOT #7011860936). - COMPETITOR'S ACETABULAR SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67537 SMR SHOULDER REVERSE LINER 40MM STANDARD PHX LIMACORPORATE S.P.A. 1365.50.810 23AT07N 08033390085014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention