BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVISION MODULAR NECK H.50MM

    MDR report key: 9984845 · Received April 22, 2020

    Report

    Report Number
    3008021110-2020-00022
    Event Type
    Injury
    Date Received
    April 22, 2020
    Date of Event
    April 3, 2020
    Report Date
    October 13, 2020
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    LZO
    PMA / PMN Number
    K151739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF THE DHR: BY CHECKING THE DHR OF THE COMPONENTS INVOLVED, NO PRE-EXISTING ANOMALY WAS DETECTED ON 42 REVISION MODULAR NECK H.50MM CODE 7515.15.005 MANUFACTURED WITH LOT #1905746 - STER. 1900148. 100 FEMORAL MODULAR HEAD - M Ø36MM CODE 5010.42.362 MANUFACTURED WITH LOT #1980810 - STER. 1900296. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT#. MEDICAL EXPERT ANALYSIS: WE RECEIVED PRE-REVISION MR IMAGES (UNKNOWN DATE) AND POST-PREVIOUS SURGERY XRAYS TAKEN ON (B)(6) 2020 AND SHARED THEM WITH A MEDICAL EXPERT FOR CLINICAL INVESTIGATION. FOLLOWING, HIS COMMENT IS REPORTED: "THE XRAYS SHOW CLEARLY THAT DISLOCATION OCCURRED BECAUSE THE MODULAR NECK ROTATED AGAINST THE STEM. THIS MAY OCCUR WHEN THE SCREW IS NOT TIGHTENED FIRMLY, WHICH IS ALREADY VISIBLE AT THE IMMEDIATE POSTOP X-RAY. THERE MAY BE 2 EXPLANATIONS: 1. THERE HAS BEEN A FAILURE OF THE IMPLANTS, EITHER THE SCREW OR THE MODULAR NECK. [..] 2. THE SURGEON DID NOT PLACE THE SCREW CORRECTLY SO THAT IT DID NOT FIX THE NECK CORRECTLY. I WOULD RATHER SUSPECT THE SECOND, AS WE CAN SEE THAT THE LOCKING SCREW WAS LOOSE. EXAMINATION OF THE EXPLANTS SHOULD SHOW, WHICH MODE ACTUALLY APPLIES. YOU SHOULD ALSO TRACE THE BATCH NUMBER (INCLUDING THE SCREW) FOR COMPARABLE FAILURES." ACCORDING TO THE MEDICAL EXPERT, ROOT CAUSE FOR DISLOCATION WAS ROTATION OF THE NECK AROUND THE STEM WHICH WAS CAUSED BY THE IMMEDIATE POST-OPERATIVE LOOSENING OF THE SCREW OF THE NECK. CAUSE FOR SCREW LOOSENING COULD HAVE BEEN FAILURE OF THE IMPLANTS OR SURGICAL MALPOSITIONING DURING PREVIOUS SURGERY. BECAUSE NO FURTHER COMPLAINTS WERE RECEIVED ON THESE LOT NUMBERS AND NO ANOMALY WAS DETECTED BY THE CHECK OF THE MANUFACTURING CHART, WE CAN HYPOTHESIZE THAT ROOT CAUSE FOR SCREW LOOSENING WAS SURGICAL ERROR. EXPLANTS ANALYSIS: EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE, ONLY MR IMAGES AND XRAYS WERE AVAILABLE FOR INVESTIGATION. BY A TECHNICAL POINT OF VIEW, THE LOOSENED SCREW HAS A SAFETY FUNCTION THAT GUARANTEES THE CORRECT POSITIONING OF THE IMPLANTS; IF DURING FIRST SURGERY THE SAFETY SCREW HAD BEEN PLACED CORRECTLY THE NECK WOULD NOT HAVE ROTATED. INSTEAD, A FEW WEEK AFTER IMPLANTATION NECK ROTATION OCCURRED, DEMONSTRATING THAT LOOSENING OF THE SCREW AND IMPLANT DISLOCATION WAS DUE TO INITIAL MALPOSITIONING. IN CONCLUSION, CONSIDERING THE MEDICAL EXPERT AND TECHNICAL OPINION, AND CONSIDERING THE COMPLIANCE OF THE MANUFACTURING CHART, ROOT CAUSE OF IMPLANT DISLOCATION AND SCREW LOOSENING IS SURGICAL FACTOR. EVENT NOT PRODUCT RELATED. PMS DATA: BASED ON OUR PMS DATA, OCCURRENCE RATE OF DISLOCATION DUE LOOSENING/ROTATION OF THE MODULAR NECK IS LOWER THAN (B)(6). NO CORRECTIVE ACTION IMPLEMENTED DUE TO THIS SPECIFIC CASE. LIMACORPORATE WILL KEEP THE MARKET MONITORED.

    Description of Event or Problem · 0

    REVISION SURGERY OF HIP IMPLANT DUE TO DISLOCATION OCCURRED ON (B)(6)2020. PREVIOUS SURGERY WAS PERFORMED ON (B)(6)2020 AND WAS A REVISION OF ANOTHER MANUFACTURER IMPLANTS. ACCORDING TO THE INFORMATION REPORTED, PATIENT DISLOCATED WHEN MOVING IN BED. PRE-REVISION MAGNETIC RESONANCE IMAGES SHOW THE PROXIMAL BODY LOCKING SCREW LOOSE. DURING REVISION, MODULAR HEAD CODE 5010.42.362 AND MODULAR NECK CODE 7515.15.005 WERE REPLACED. SURGEON WAS HAPPY WITH THE FINAL STABILITY OF THE IMPLANT. NO OTHER INFORMATION AVAILABLE. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE COMPONENTS INVOLVED, NO PRE-EXISTING ANOMALY WAS DETECTED ON 42 REVISION MODULAR NECK H.50MM CODE 7515.15.005 MANUFACTURED WITH LOT #1905746 - STER. 1900148. 100 FEM. MODULAR HEAD - M Ø36MM CODE 5010.42.362 MANUFACTURED WITH LOT #1980810 - STER. 1900296. THIS IS THE FIRST AND OBLY COMPLAINT RECEIVED ON THESE LOT#. WE WILL SUBMIT A FINAL INCIDENT REPORT ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY OF HIP IMPLANT DUE TO DISLOCATION OCCURRED ON (B)(6) 2020. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2020 AND WAS A REVISION OF ANOTHER MANUFACTURER IMPLANTS. ACCORDING TO THE INFORMATION REPORTED, PATIENT DISLOCATED WHEN MOVING IN BED. PRE-REVISION MAGNETIC RESONANCE IMAGES SHOW THE PROXIMAL BODY LOCKING SCREW LOOSE. DURING REVISION, MODULAR HEAD CODE 5010.42.362 AND MODULAR NECK CODE 7515.15.005 WERE REPLACED. SURGEON WAS HAPPY WITH THE FINAL STABILITY OF THE IMPLANT. NO OTHER INFORMATION AVAILABLE. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450307 REVISION MODULAR NECK H.50MM REVISION MODULAR NECK H.50MM (LZO-LPH-KWY) LZO LIMACORPORATE SPA 7515.15.005 1905746

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention