BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMENT G

    MDR report key: 17910734 · Received October 11, 2023

    Report

    Report Number
    3005304945-2023-00002
    Event Type
    Injury
    Date Received
    October 11, 2023
    Date of Event
    July 20, 2023
    Report Date
    October 3, 2023
    Manufacturer
    BONESUPPORT AB
    Product Code
    QRR
    PMA / PMN Number
    DEN210044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: WE USED THE INFORMATION FROM THE OBSERVATION FORM, THE CALL WITH THE HOSPITAL AND EVALUATED THE AVAILABLE RADIOGRAPHS AND PHOTO. - THE FIRST AP AND LAT RADIOGRAPH (PRE-OPERATIVE) IS DATED (B)(6) 2023 (THEY WERE MADE 4 MONTHS BEFORE OPERATION). THEY SHOW THE FILLING OF A BONE VOID AT THE PROXIMAL TIBIA WITH SOME NONABSORBABLE BONE SUBSTITUTES WHICH WAS NOT MENTIONED IN PATIENTS' HISTORY OF THE DISEASE. FROM THE TYPICAL ASPECT ON THE RADIOGRAPHS WE SUSPECT THAT THE NON-ABSORBABLE BONE SUBSTITUTE IS PMMA BONE CEMENT. THE BONE VOID IS COMPLETELY FILLED, BUT NOT OVERFILLED, SINCE THE CORTICAL LINING OF THE TIBIA IS WELL VISIBLE. - THE NEXT AP AND LAT RADIOGRAPH (POST-OPERATIVE) IS DATED (B)(6) 2023 AFTER WITH THE SURGERY WHERE CERAMENT G WAS USED. ON THE AP RADIOGRAPH A BLOCK OF CERAMENT G CAN BE SEEN LATERAL TO THE BONE DEFECT, INSIDE THE SOFT TISSUE AND NOT FAR FROM THE SKIN. IT SEEMS LIKE THE CERAMENT WAS PLACED IN THE SOFT TISSUE OR MIGRATED IMMEDIATELY AFTER SURGERY INTO THE SOFT TISSUE. THERE ARE THREE SMALLER PARTS OF CERAMENT G. ONE OF THEM PROBABLY FILLS A SMALLER, MORE DISTAL BONE VOID. THE OTHER TWO PARTS ARE AGAIN FOUND IN THE SOFT TISSUE. ON THE LAT. RADIOGRAPH CERAMENT IS PROJECTED ON THE TIBIAL HEAD; HOWEVER, IN THIS PROJECTION IT IS NOT POSSIBLE TO DECIDE, IF CERAMENT IS INSIDE OR OUTSIDE OF THE BONE VOID. - THE LAST THREE RADIOGRAPHS (THREE WEEKS AFTER THE FIRST SURGERY) ARE DATED (B)(6) 2023 AND HAVE BEEN TAKEN AFTER PERFORMING THE REVISION SURGERY. THE RADIOGRAPHS SHOW THAT CERAMENT G HAS BEEN REMOVED AND THE BONE VOIDS NOW FILLED WITH A BLOCK OF PMMA, AS DESCRIBED IN THE SURGICAL NOTE. ON THE AP RADIOGRAPH IT LOOKS LIKE AS THE COMPLETE BONE VOID HAS BEEN FILLED; MAYBE A BIT OVERFILLED. - ONE PHOTO WAS ATTACHED TO THE OBSERVATION FORM. IT SHOWS WOUND BREAKDOWN AND WOUND DEHISCENCE. CERAMENT G IS VISIBLE THROUGH THE DEHISCENT AT THE LEFT CORNER OF THE WOUND. THE IMMEDIATE POST-OPERATIVE RADIOGRAPHS SHOW THAT CERAMENT G IS NOT PLACED INSIDE THE BONE VOID, BUT IN THE ADJACENT SOFT TISSUE. WE ASSUME THAT IT HAS BEEN PLACED THERE UNINTENDEDLY OR IS MIGRATED OUT OF THE VOID DURING SURGERY. THIS CAN HAPPEN WHEN THE MATERIAL IS NOT PRESSED INTO THE BONE DEFECT. WE SEE THIS AS A KNOWLEDGE BASED /RULE BASED / SKILLED BASED FAILURE, SINCE IT SEEMS THAT IT HAPPENED DURING OR IMMEDIATELY POST OPERATIVELY. WITHOUT THE CONTACT TO LIVING BONE, CERAMENT CANNOT PERFORM ITS PRIMARY MODE OF ACTION, WHICH IS REMODELING TO BONE WITHIN 6 TO 12 MONTHS. PLACED INSIDE THE SOFT TISSUE, CERAMENT G DEGRADES FASTER AND CAN LEAD TO A SOFT TISSUE INFLAMMATION. IN THIS CASE THE SOFT TISSUE INFLAMMATION LED TO A SERIOUS DETERIORATION IN THE HEALTH STATUS, REQUIRING SECOND OPERATION, AND THUS THIS EVENT WAS REPORTABLE TO THE REGULATORY AUTHORITY. REVIEW OF BATCH RECORDS FOR LOT MLOT0913 INCLUDING QUALITY RELEASE RESULTS HAVE BEEN PERFORMED. ALL RESULTS FROM RELEASE TESTS WERE WITHIN LIMITS AND NO IRREGULARITIES REGARDING PERFORMANCE FOR THIS PRODUCT LOT HAS BEEN FOUND. THE FIRST DEVICE FROM THE LOT WAS SOLD (B)(6) 2022. AS PER THE (B)(6) 2023, ALL EXCEPT 2 DEVICES OF THE TOTAL LOT SIZE OF (B)(4) DEVICES HAVE BEEN SOLD. DUE TO EXPECTED SALES PATTERN, IT IS HIGHLY LIKELY THAT THE MAJORITY OF THE SOLD DEVICES HAVE BEEN IMPLANTED. EXPIRATION DATE OF THE LOT WAS (B)(6) 2023. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THE LOT. RISK ASSSSMENT / INSTRUCTIONS FOR USE: THE OCCURRED EVENT IS COVERED BY RISKS IN THE RISK ASSESSMENT (B)(4) AND PRECAUTIONS/DIRECTIONS FOR USE IN THE INSTRUCTIONS FOR USE (IFU0014-11): OVERFILLING IS DESCRIBED ACCORDING TO RISK ID U.4.17: "KNOWLEDGE BASED /RULE BASED / SKILLED BASED FAILURE:" "SURGEON OVERFILLS THE DEFECT RESULTING IN MATERIAL IN SOFT TISSUE" LEADING TO THE PRECAUTIONS AND DIRECTION FOR USE IN THE INSTRUCTIONS FOR USE: - "DO NOT OVERFILL." - "MAY CAUSE INFLAMMATORY REACTION IF PRESENT IN SOFT TISSUE." - "PROCEED UNTIL THE GAP/VOID IS FILLED WITH AN ADEQUATE AMOUNT OF PASTE, AS JUDGED BY THE RESPONSIBLE PHYSICIAN." MOREOVER REGARDING LEAKAGE, RISK ID D.1.2.4: "CERAMENT G LEAKS TO THE SOFT TISSUE DUE TO UNCONTAINED VOID". RISK ID U.4.3: "LEAKAGE OF CERAMENT OUTSIDE THE INTENDED AREA WHEN INJECTING". RISK ID U.5.4 AND U.5.5 "CG LEAKS TO THE SOFT TISSUE". WITH THE FOLLOWING DIRECTIONS FOR USE AND PRECAUTION IN THE INSTRUCTIONS FOR USE: - "CLOSE THE WOUND METICULOUSLY TO AVOID LEAKAGE INTO SOFT TISSUE. FOLLOW ACCEPTED CLINICALNPRACTICE FOR POSTOPERATIVE CARE." - "CAREFULLY INJECT MATERIAL FROM CERAMENT ID INTO THE BONE GAP/VOID UNDER VISUAL INSPECTION". - "MAY CAUSE INFLAMMATORY REACTION IF PRESENT IN SOFT TISSUE". CONCLUSIONS: THE IMMEDIATE POST-OPERATIVE RADIOGRAPHS SHOW THAT CERAMENT G WAS NOT PLACED INSIDE THE BONE VOID, BUT IN THE ADJACENT SOFT TISSUE. IT IS ASSUMED THAT IT HAS BEEN PLACED THERE UNINTENDEDLY OR IS MIGRATED OUT OF THE VOID DURING OR DIRECTLY AFTER SURGERY. THIS CAN HAPPEN WHEN THE MATERIAL IS NOT PRESSED INTO THE BONE DEFECT. THE SOFT TISSUE INFLAMMATION REQUIRED A SECOND OPERATION, AND THUS THIS EVENT IS CONSIDERED TO HAVE LED TO A SERIOUS DETERIORATION IN THE HEALTH STATUS, MEANING IT IS REPORTABLE TO THE REGULATORY AUTHORITY. EVALUATION OF BATCH RECORDS FOR THE PRODUCT LOT USED HAS SHOWN NO IRREGULARITIES REGARDING PERFORMANCE AND THERE HAVE BEEN NO SIMILAR COMPLAINTS. BASED ON OUR INVESTIGATION THE LIKELY CAUSE OF THE EVENT IS A KNOWLEDGE BASED /RULE BASED / SKILLED BASED FAILURE, SINCE IT CAN BE SUSPECTED THAT INSTRUCTIONS FOR USE HAVE NOT BEEN COMPLETELY ADHERED TO. HOWEVER, IT CANNOT BE RULED OUT THAT CERAMENT HAS CONTRIBUTED TO THIS SERIOUS INJURY. RISK ASSESSMENT, PRECAUTIONS AND DIRECTIONS FOR USE IN INSTRUCTIONS FOR USE ALREADY COVER THE OCCURRED EVENT, AND HENCE IT CAN BE CONCLUDED THAT THERE ARE NO CORRECTIVE ACTIONS REQUIRED. PLEASE NOTE THAT THIS EVENT WAS INITAILLY ASSESSED NOT TO BE REPORTABLE IN THE US. DURING THE INVESTIGATION ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEADING TO A CHANGED AUTHORITY REPORTING DECISION ON (B)(6) 2023 AND THAT THE EVENT WAS REPORTABLE TO FDA.

    Description of Event or Problem · 0

    THE FOLLOWING IS INFORMATION EXTRACTED FROM THE ANSM REPORT IN FRENCH ((B)(4)) AND THEN TRANSLATED TO ENGLISH BY GOOGLE TRANSLATE: "DATE OF OCCURRENCE: (B)(6) 2023. DESCRIPTION OF INCIDENT: CONVICTION STUDY AS PART OF A CLINICAL RESEARCH PROJECT AT BREST UNIVERSITY HOSPITAL SEE OPERATIVE REPORT OF (B)(6) 2023 FOR PLACEMENT OF ANTIBIOTIC CEMENT: CHRONIC OSTEITY OF THE PROXIMAL TIBIA LEFT WITH PRESENCE OF A PRODUCTIVE CUTANEOUS FISTULA ON THE LATERAL SIDE SEE OPERATIVE REPORT OF (B)(6) 2023 FOR REMOVAL OF ANTIBIOTIC CEMENT: ISCHEMIC PAIN ON D1 OF A LGAP FLAP FOR COVERING A LOSS OF SUBSTANCE ON THE LATERAL ASPECT OF THE PROXIMAL TIBIA OF THE LEFT LEG, HAVING NECESSITATED THE REMOVAL OF THE STITCHES FROM THE LOWER PART OF THE FLAP, RESULTING FROM THE CERAMENT CEMENT BY THE SCAR. CURRENT CONDITION OF THE PATIENT: SEE OPERATIVE REPORT OF (B)(6) 2023 FOR REMOVAL OF ANTIBIOTIC CEMENT : SUFFERING ISCHEMIC ON DAY 1 OF AN LGAP FLAP TO COVER A LOSS OF SUBSTANCE ON THE LATERAL FACE OF THE PROXIMAL TIBIA OF THE LEFT LEG, HAVING REQUIRED THE REMOVAL OF THE STITCHES FROM THE LOWER PART OF THE FLAP, RESULTING FROM THE CEMENT CERAMENT BY THE SCAR ACTIONS TAKEN IN THE HEALTHCARE FACILITY FOR PATIENT CARE: SEE OPERATIVE REPORT OF THE (B)(6) 2023 FOR WITHDRAWAL OF ANTIBIOTIC CEMENT : ISCHEMIC PAIN ON D1 OF AN LGAP FLAP FOR THE COVERAGE OF A E LOSS OF SUBSTANCE OF THE LATERAL ASPECT OF THE PROXIMAL TIBIA OF THE LEFT LEG, HAVING REQUIRED THE REMOVAL OF STITCHES". THE FOLLOWING INFORMATION HAS BEEN RECEIVED FROM HOSPITAL: EVENT DESCRIPTION: IMPLANTATION OF CERAMENT G ON (B)(6) 2023. 3 WEEKS LATER REVISION SURGERY WITH REMOVAL OF CERAMENT. PRE-OPERATIVE DIAGNOSIS: AJL ISCHEMIC PAIN FROM AN LGAP FLAP TO COVER A LOSS OF SUBSTANCE OF THE LATERAL ASPECT OF THE PROXIMAL TIBIA OF THE LEFT LEG, HAVING REQUIRED THE REMOVAL OF STITCHES FROM THE LOWER PART OF THE FLAP; LEAKAGE OF THE CERAMENT CEMENT THROUGH THE SCAR. DAMAGE DESCRIPTION: WOUND BREAKDOWN AND WOUND LEAKAGE. INTERVENTION DESCRIPTION: REVISION SURGERY ON (B)(6) 2023 AND PROLONGED HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238044 CERAMENT G CERAMENT G QRR BONESUPPORT AB A0450-01 MLOT0913

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention| O| H