BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREHIP STD CEMENTLESS 12/14 SIZE 3

    MDR report key: 19182532 · Received April 25, 2024

    Report

    Report Number
    9610612-2024-00141
    Event Type
    Injury
    Date Received
    April 25, 2024
    Date of Event
    November 27, 2023
    Report Date
    April 30, 2025
    Manufacturer
    AESCULAP AG
    Product Code
    LZO
    PMA / PMN Number
    K172235
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DATE OF AWARENESS HAS BEEN UPDATED TO 11NOV2023.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 - CODES UPDATED. INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS BASED UPON HISTORICAL DATA ANALYSIS, AND EVENT DESCRIPTION. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. ALSO AFTER MEANINGFUL ATTEMPTS NO FURTHER INFORMATION COULD BE RECEIVED. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON -ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION. CONCLUSION/PREVENTIVE MEASURES: BASED ON THE CURRENT INFORMATION AND WITHOUT THE PRODUCT FOR INVESTIGATION, A CLEAR CONCLUSION CANNOT BE DRAWN. THE REPORTED FAILURE OR DEVIATION COULD NOT BE CONFIRMED. THERE IS NO INDICATION FOR A MATERIAL DEFECT OR MANUFACTURING FAILURE. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. THE FOLLOWING INFORMATION IS CONTAINED IN THE INSTRUCTION FOR USE: 2.2.3 ABSOLUTE CONTRAINDICATIONS. DO NOT USE: O IN PATIENTS FOR WHOM RECONSTRUCTIVE SURGERY TO TREAT THE JOINT CONDITION IS AN OPTION. O IN CASE OF ACUTE OR CHRONIC INFECTIONS NEAR THE JOINT. O IN CASE OF SECONDARY DISEASES INFLUENCING THE FUNCTION OF THE JOINT IMPLANT. O IN CASE OF SEVERE OSTEOPOROSIS OR OSTEOMALACIA WITH CEMENTLESS IMPLANTS. O IN CASE OF POOR BONE QUALITY AND OSSEOUS MALFORMATIONS, DISEASES IN THE AREA OF THE IMPLANT FIXATION, WHICH MAY PRIMARILY OR SUBSEQUENTLY AFFECT THE STABILITY OF THE JOINT REPLACEMENT ANCHORAGE. O IN CASE OF KNOWN HYPERSENSITIVITY TO THE IMPLANT MATERIALS. O IN ALL OF THE AREAS OF APPLICATION NOT LISTED UNDER INDICATIONS. 2.3 RISKS, ADVERSE EFFECTS AND INTERACTIONS. WITHIN THE SCOPE OF THE LEGAL OBLIGATION TO PROVIDE INFORMATION, REFERENCE IS MADE TO THE TYPICAL RISKS, INTERACTIONS AND SIDE EFFECTS LISTED BELOW. POSSIBLE RISKS, SIDE EFFECTS AND INTERACTIONS OF THE APPLICATION CURRENTLY KNOWN TO THE MANUFACTURER ARE: O DISLOCATION, LOOSENING, WEAR, CORROSION, DISCONNECTION AND BREAKAGE OF THE IMPLANT COMPONENTS. O JOINT DISLOCATION AND POSTOPERATIVE CHANGES IN LEG LENGTH. O PRIMARY AND SECONDARY INFECTIONS. O PERIPROSTHETIC FRACTURES. O THROMBOSES, EMBOLISMS. O TISSUE REACTION TO IMPLANT MATERIALS. O INJURY TO THE SURROUNDING TISSUE, INCLUDING NERVE AND VASCULAR DAMAGE O HAEMATOMA AND WOUND HEALING DISORDERS. O PERIARTICULAR CALCIFICATION. O REDUCED JOINT MOBILITY AND FLEXIBILITY. O LIMITED LOAD-BEARING ABILITY OF THE JOINT AND JOINT PAIN. 2.6.2 IMPLANTATION. NOTE FOR DETAILED INFORMATION OF IMPLANTATION STEPS SEE IMPLANT SYSTEM SPECIFIC OPERATING TECHNIQUE INSTRUCTIONS. THE DIFFERENT IMPLANT LINES OF THE COREHIP® HIP ENDOPROSTHESIS SYSTEM ARE CONSISTENTLY MARKED BY DIFFERENT COLORS: O VARA LINE: GREEN. O STANDARD LINE: YELLOW. O VALGA LINE: BLUE. O DYSPLASIA LINE: RED THE IMPLANTATION AND IMPLANTATION SITE ARE PREPARED IN THE FOLLOWING WAY: O FOLLOWING THE FEMORAL HEAD OSTEOTOMY, OPEN THE FEMUR WITH THE COREHIP® BOX OSTEOTOME. O PREPARE THE MEDULLARY CAVITY WITH COREHIP® RASPS OF ASCENDING SIZES. NOTE THE COREHIP® RASPS HAVE DIFFERENT MARKINGS FOR THE HEIGHT OF THE PROSTHESIS SHOULDER AND THE FEMORAL OSTEOTOMY. O ALWAYS DRIVE IN THE RASP ONLY AS FAR AS THE MARKING OF THE PLANNED IMPLANT LINE. O CARRY OUT INTRAOPERATIVE ALIGNMENT OF THE IMPLANT COMPONENTS, OBSERVING THE RESECTION LINE. O FOR CEMENT-FREE IMPLANTATION: SELECT THE IMPLANT SIZE EQUIVALENT TO THE SIZE OF THE LAST RASP INSERTED IN THE CORRECT POSITION. NOTE FOR CEMENTED IMPLANTATION: THE SIZE OF THE RASP CORRESPONDS TO THE SIZE OF THE IMPLANT. O FOR CEMENTED IMPLANTATION: SELECT THE IMPLANT SIZE BASED ON THE DESIRED CEMENT MANTLE. THE DESIRED CEMENT MANTLE THICKNESS IS ACHIEVED VIA THE CORRESPONDINGLY SMALLER SIZE OF THE IMPLANT. O FOR CEMENTED IMPLANTATION: USE A CENTRALIZER SIZE THAT IS SUITABLE FOR THE SIZE OF THE SELECTED IMPLANT. WARNING BONE FRACTURES IN THE IMPLANT BED WILL AFFECT THE ANCHORING OF THE IMPLANTS! O AVOID BONE FRACTURES BY USING CAUTIOUS SURGICAL TECHNIQUE. O TREAT BONE FRACTURES WITH APPROPRIATE INTRA- AND POSTOPERATIVE MEASURES. O OBSERVE THE CORRECT APPLICATION OF THE IMPLANT COMPONENTS. O MAKE CERTAIN THE TAPER SIZES OF THE PROSTHESIS STEMS MATCH THE CONE SIZES OF THE PROSTHESIS HEADS (SEE CONE SIZE ON IMPLANT PACKAGING, E.G. 12/14). O PERFORM A TRIAL REPOSITIONING AND CHECK JOINT MOBILITY, JOINT STABILITY AND LEG LENGTH BEFORE INSERTING THE IMPLANTS. O WHEN IMPLANTING HIP ENDOPROSTHESIS HEADS, ALWAYS MAKE SURE THAT: - THE PROTECTIVE CAP ON THE PROSTHESIS STEM TAPER IS REMOVED ONLY IMMEDIATELY BEFORE THE PROSTHESIS HEAD IS INSERTED. - BOTH THE OUTSIDE TAPER OF THE PROSTHESIS STEM AND THE INSIDE TAPER OF THE PROSTHESIS HEAD ARE CLEAN AND DRY PRIOR TO FITTING THE PROSTHESIS HEAD. - ALL FOREIGN BODIES, SUCH AS TISSUE FRAGMENTS AND BONE OR CEMENT PARTICLES, ARE REMOVED. - THE PROSTHESIS HEAD IS FITTED UNDER AXIAL PRESSURE WITH A SLIGHT ROTATION AND SECURED BY A BLOW WITH A MALLET ON A PLASTIC (NOT METAL) HEAD IMPACTOR. - ALL EXPOSED FOREIGN BODIES SUCH AS BONE CEMENT AND BONE RESIDUES ARE REMOVED PRIOR TO CLOSING THE WOUND, BECAUSE BONE CEMENT PARTICLES AND BONE FRAGMENTS THAT GET CAUGHT BETWEEN THE SLIDING SURFACES CAN CAUSE ABNORMAL WEAR OF THE ARTIFICIAL JOINT. O PREPARE AND APPLY BONE CEMENT AS DESCRIBED IN THE USER INSTRUCTIONS PROVIDED BY THE CEMENT SUPPLIER. O FOLLOW THE INSTRUCTIONS FOR USE OF AESCULAP CENTRALIZERS (B)(4). O BEFORE CLOSING THE WOUND, CHECK THE POSITIONING AND ORIENTATION OF THE IMPLANT COMPONENTS, IF NECESSARY, BY MEANS OF FLUOROSCOPY. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NK1003T - COREHIP STD CEMENTLESS 12/14 SIZE 3. ACCORDING TO THE COMPLAINT DESCRIPTION, WHILE PLACING THE STEM, A BONE CRACK ON THE MEDIAL SIDE OF FEMUR WAS OBSERVED. THE STEM WAS REPLACED WITH CEMENTED NON-AESCULAP STEM. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614652 COREHIP STD CEMENTLESS 12/14 SIZE 3 HIP ENDOPROSTHETICS LZO AESCULAP AG NK1003T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention