BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FEM HD 28/0MM T1

    MDR report key: 8892008 · Received August 14, 2019

    Report

    Report Number
    3002806535-2019-00674
    Event Type
    Injury
    Date Received
    August 14, 2019
    Date of Event
    July 11, 2019
    Report Date
    September 24, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K131684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CMP-(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G4, G7, H1, H2, H4, H6, H10. TWO RADIOGRAPHS, TAKEN ON 29TH JUNE 2019, HAVE BEEN PROVIDED FOR ANALYSIS WITH CMP-0527367: ONE ANTEROPOSTERIOR AND ONE MEDIOLATERAL. IN BOTH XRAYS, CERAMIC MATERIAL IS VISIBLE IN THE MEDIAL JOINT SPACE, WHICH IS ASSUMED TO BE FRAGMENTS OF THE FRACTURED BIOLOX DELTA HEAD AND/OR LINER. THE PATIENT HAD A HEIGHT OF 158 CM AND A WEIGHT OF 58 KG AT THE TIME OF SURGERY, AND THEREFORE A BMI OF 23.2 (NORMAL WEIGHT). THE PATIENT¿S POSTOPERATIVE ACTIVITY LEVEL WAS ''GOOD''. DUE TO THE LACK OF BONE STRUCTURES VISIBLE ON THE X-RAYS, IT IS NOT POSSIBLE TO MEASURE THE INCLINATION AND ANTEVERSION ANGLES OF THE ACETABULAR SHELL. IT IS MENTIONED IN THE EA LOG QUESTIONNAIRE FINAL SECTION ON ETQ THAT THE SURGICAL TECHNIQUE FOR THE PRODUCT WAS UTILIZED. HOWEVER, IN THE SURGICAL NOTES THERE IS NO REFERENCE TO THE INCLINATION AND ANTEVERSION ANGLES THAT THE ACETABULAR CUP WAS PLACED AT. THE EXCEED ABT SURGICAL TECHNIQUE RECOMMENDS CUPS TO BE POSITIONED AT 40 TO 45 DEGREES OF INCLINATION AND IN 20 TO 25 DEGREES OF ANTEVERSION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION DUE TO A FRACTURE OF THE LINER AND FEMORAL HEAD.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN - EVENT OCCURRED IN (B)(6). CONCOMITANT MEDICAL PRODUCTS: BIOLOX DELTA LNR 28MM 46-48MM CATALOG #: 650-0790, LOT #: 2016031936; EXCEED ABT 3HL SHELL 37/48MM, CATALOG #: 123748, LOT #: 3914211; ECHO POR FMRL RED NC 9X125MM, CATALOG #: 192409, LOT #: 372310; TI LOW PROFILE SCREW 6.5X25MM, CATALOG #: 103532, LOT #: 597080. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION DUE TO A FRACTURE OF THE LINER AND FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686068 DELTA CER FEM HD 28/0MM T1 HIP PROSTHESIS LZO BIOMET UK LTD. N/A 2016061371

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R SEE H10