BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL

    MDR report key: 18825307 · Received March 4, 2024

    Report

    Report Number
    0001822565-2024-00726
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    August 26, 2021
    Report Date
    July 23, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024123816
    PMA / PMN Number
    K972774
    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: 00620005622 SHELL POROUS WITH CLUSTER HOLES 56 MM O.D. 62954811. 00625006550 BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH 63003489. 650-0662 DELTA CERAMIC FEM HD 36/+3MM 3053017. 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

    REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT FOR THE LINER. 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.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177100 LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL PROTHESIS, HIPS JWH ZIMMER BIOMET, INC. N/A 63687030 00889024123816

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Hospitalization| R SEE H10 NARRATIVE.