BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELL POROUS WITH CLUSTER HOLES 56 MM O.D.

    MDR report key: 17938603 · Received October 16, 2023

    Report

    Report Number
    0002648920-2023-00246
    Event Type
    Injury
    Date Received
    October 16, 2023
    Date of Event
    August 25, 2021
    Report Date
    July 23, 2024
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 00801803602 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER 63091602. 00771101200 FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 12.5 STANDARD OFFSET 63026791. 00630505636 LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL 63011059. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920 -2023 -00249. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: 00630505636 LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL 63687030, 650-0662 DELTA CERAMIC FEM HD 36/+3MM 3053017.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: G3, G6, H2, H4, H6. REVIEW OF COMPLAINT HISTORY IDENTIFIED NO ADDITIONAL COMPLAINTS FOR THE SHELL AND NO ADDITIONAL COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL LEFT THA WAS PERFORMED. THE PATIENT HAS UNDERGONE TWO REVISIONS AND DUE TO LOOSENING OF THE STEM AND FRACTURE OF THE REVISION STEM. THE PATIENT UNDERWENT A THIRD REVISION DUE TO DISLOCATION, INSTABILITY, AND PAIN. LEADING UP TO THE REVISION, THE PATIENT EXPERIENCED A HEMATOMA THAT WAS RESOLVED PRIOR TO SURGERY. DURING SURGERY, THE SHELL WAS WELL FIXED BUT REMOVED TO IMPROVE STABILITY. THE SHELL, LINER, HEAD, AND SCREW WERE EXPLANTED AND REPLACED WITH ZB PRODUCTS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE INSTABILITY, PAIN, AND DISLOCATIONS. NO PROBLEM WAS FOUND WITH ALL DEVICES IN RELATION TO THE HEMATOMA AFTER REVIEW BY A HCP. NO PROBLEM WAS FOUND WITH THE SCREW UPON RECEIPT OF THE MEDICAL RECORDS. THIS COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE COMPLAINT CANNOT BE CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 THE PATIENT HAD AN INITIAL LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED SIX YEARS (6) POST IMPLANTATION DUE TO LOOSENING, INSTABILITY, AND IMPLANT FAILURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. ONE YEAR POST IMPLANTATION, THE HEAD AND STEM WERE REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT WITH FAILURE TO OSSEOINTEGRATE. THE PATIENT WAS REVISED FOR A SECOND TIME, FIVE YEARS POST IMPLANTATION DUE TO FRACTURE OF THE REVISION STEM WITH COMPLICATED EXTRACTION VIA EXTENDED TROCHANTERIC OSTEOTOMY. AFTER THE SECOND REVISION, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS REQUIRING CLOSED REDUCTION UNDER ANESTHESIA. A THIRD REVISION WAS PLANNED BUT DELAYED DUE TO DIFFICULTY EXTUBATING THE PATIENT AND THE CONCURRENT ONSET BILATERAL PULMONARY EMBOLISMS. AFTER THE PATIENT¿S PULMONARY FUNCTION AND ANTICOAGULATION MEASURES WERE STABILIZED, THE REVISION OCCURRED DURING WHICH, MULTIPLE HEMATOMAS WERE EVACUATED FROM THE JOINT, AND POSTERIOR INSTABILITY WAS CONFIRMED ON EXAM. UPON REPLACING THE ACETABULAR SHELL, ANTEVERSION WAS INCREASED BY 15 DEGREES. A NEW CONSTRAINED HEAD AND LINER WERE PLACED WITHIN THE SHELL, AND THE REVISION STEM WAS RETAINED. POSTOPERATIVELY, THE PATIENT DEMONSTRATED SLOW BUT STEADY PROGRESS WITH INTENSIVE PHYSICAL THERAPY.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415587 SHELL POROUS WITH CLUSTER HOLES 56 MM O.D. PROTHESIS, HIPS LPH ZIMMER MANUFACTURING B.V. N/A 62954811

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention| H SEE H10 NARRATIVE.| SEE H10 NARRATIVE.