BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW SELF-TAPPING 6.5 MM DIA. 70 MM LENGTH

    MDR report key: 16875602 · Received May 5, 2023

    Report

    Report Number
    0002648920-2023-00088
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 24, 2023
    Report Date
    July 29, 2023
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    UDI-DI
    00889024119871
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A2: YEAR OF BIRTH: 1938 . D10: MEDICAL PRODUCT: BURCH-SCHNEIDER, REINFORCEMENT CAGE, NEW, LEFT, 56: CATALOG#0100191156, LOT#3145853; DURASUL, LOW PROFILE CUP, CEMENTED, 56/36: CATALOG#0595001054, LOT#3076489; BONE SCREW SELF-TAPPING 6.5 MM DIA. 70 MM LENGTH : CATALOG#00625006570, LOT#63486223; COCR HEAD, L, ø 36/+4, TAPER 12/14: CATALOG#0101012367, LOT#3043232; FITMORE®, HIP STEM, UNCEMENTED, OFFSET B (EXTENDED)/8, TAPER 12/14: CATALOG#0100551308, LOT#3142451. G2: FOREIGN: GERMANY. TWO (2) SCREWS HAVE BEEN REPORTED FOR THIS EVENT. AT THE TIME OF THIS REPORT, IT IS UNKNOWN WHICH SCREW IS IMPLICATED IN THE ADVERSE EVENT. BOTH HAVE BEEN REPORTED UNDER THE FOLLOWING ASSOCIATED REPORT: 0002648920-2023-00089. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROGRESS. UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: MEDICAL PRODUCT: B-S REINFORCMNT RING NEW 56 LT: CATALOG#01.00191.156, LOT#3145853; DURASUL, LOW PROFILE CUP, CEMENTED, 56/36: CATALOG#0595001054, LOT#3076489; BONE SCREW SELF-TAPPING 6.5 MM DIA. 70 MM LENGTH : CATALOG#00625006570, LOT#63486223; COCR HEAD, L, ø 36/+4, TAPER 12/14: CATALOG#0101012367, LOT#3043232; FITMORE®, HIP STEM, UNCEMENTED, OFFSET B (EXTENDED)/8, TAPER 12/14: CATALOG#0100551308, LOT#3142451; UNKNOWN SPONIOSA SCREW: CATALOG#418.070, LOT#NI; UNKNOWN SPONIOSA SCREW: CATALOG#418.075, LOT#NI; UNKNOWN SPONIOSA SCREW: CATALOG#418.050, LOT#NI; UNKNOWN BONE CEMENT: CATALOG#NI, LOT#NI. THE INVESTIGATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL LEFT TOTAL HIP ARTHROPLASTY WAS PERFORMED WHERE 2 6.5MM SCREWS WERE PLACED FOR FIXATION OF A CAGE. ONE SCREW EMERGED PAST THE CAGE, AND THUS WAS REMOVED AND REPLACED WITH A COMPETITOR'S SCREW THAT SLIPPED THROUGH THE CAGE AS WELL AND REMAINS IMPLANTED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LEFT TOTAL HIP ARTHROPLASTY, ALSO WITH ACETABULAR RECONSTRUCTION. LATERAL MOST SCREW ALONG THE SUPERIOR ACETABULAR COMPONENT MAY HAVE SLIPPED THROUGH THE HOLE BUT DIFFICULT TO EVALUATE ON THESE IMAGES. THIS IS LIKELY OF NO CLINICAL SIGNIFICANCE. THIS IS LIKELY RELATED TO THE 8MM COMPETITOR'S SCREW THAT SLIPPED THROUGH THE HOLE AND REMAINS IMPLANTED. THIS COMPLAINT HAS BEEN CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO USER ERROR, AS THE SCREW AND CAGE USED TOGETHER ARE NOT COMPATIBLE. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT REGARDING PROPER USE OF THE DEVICE AND AUTHORIZED COMBINATIONS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY. WHEN PLACING THE BONE SCREW IN THE ACETABULAR REGION, IT WAS NOTICED THAT THE SCREW HEAD SLIPPED THROUGH THE HOLE IN THE IMPLANT AND CAME TO REST BEHIND THE IMPLANT DURING FINAL TIGHTENING. THERE WAS A DELAY OF 120 MINUTES WHILE THE SURGEON ATTEMPTED TO REMOVE THE SCREW, BUT WAS UNABLE. THE SCREW REMAINS IN THE PATIENT. DUE DILIGENCE IS IN PROCESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL LEFT HIP ARTHROPLASTY, A SCREW SLIPPED THROUGH THE HOLE AND EMERGED PAST THE CAGE. THE SCREW WAS ABLE TO BE REMOVED WITHOUT INCIDENT AND WAS REPLACED WITH A COMPETITOR'S SCREW WHICH ALSO SLIPPED AND REMAINS IMPLANTED. OPERATIVE NOTES INDICATED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PREVIOUSLY REPORTED PATIENT IMPACT AND SERIOUS INJURY. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS HAVE BEEN MADE HOWEVER IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468289 BONE SCREW SELF-TAPPING 6.5 MM DIA. 70 MM LENGTH PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. 6250-65-70 63486224 00889024119871

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Other SEE H10 NARRATIVE| SEE H10 NARRATIVE.