BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCR 6.5X40 SELF-TAP

    MDR report key: 18245616 · Received December 1, 2023

    Report

    Report Number
    0002648920-2023-00291
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    February 3, 2022
    Report Date
    March 11, 2024
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    UDI-DI
    00889024119840
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 110010268; G7 OSSEOTI; MULTIHOLE 60MM G 7024727; 010001003; G7 SCREW 6.5MM X 50MM; 6468223; 010001000; G7 SCREW 6.5MM X 35MM; 7073501; 010000998; G7 SCREW 6.5MM X 25MM; 6847824; 11-301241; ARCOS CAL SZ A STD +20 60MM 768840; 00-2232-001-18; 1.8MM STAINLESS STEEL CABLE 65223148; 00-2232-001-18; 1.8MM STAINLESS STEEL CABLE 65202341; 00-4894-054-10 ACET AUGM SIZE 54. 10MM THICK; 64803382; 00-4199-001-38; ACET RESTRICTOR 38MM DIA; 64583137; 11-300615; ARCOS 15X200MM PRX TPR DIST; 363960; 110024465; G7 DUAL MOBILITY LINER 46MM G; 357930; EP-200152; ACT ARTIC E1 HIP BRG 28X46MM 348730; 650-1067; CER OPTION TYPE 1 TPR SLEVE +3 3087988; 650-1055; CER BIOLOXD OPTION HD 28MM 3087109; 281001100; BALL NOSE GUIDE WIRE 100CM 165570. G2: FOREIGN: SOUTH AFRICA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920-2023-00292. 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 AND/OR CORRECTED INFORMATION. B3: DATE OF EVENT HAS BEEN UPDATED TO ¿UNKNOWN¿ TO ALIGN WITH WHEN THE PATIENT¿S FALL OCCURRED WHICH IS UNKNOWN. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PROGRESSIVE OSTEOLYSIS ALONG BOTH THE FEMORAL AND ACETABULAR IMPLANTS OF THE LEFT HIP ARTHROPLASTY AS NOTED WITH LOOSENING AND VERTICAL MALROTATION OF THE ACETABULAR IMPLANT. A LEFT HIP ARTHROPLASTY IS PRESENT WITH EVIDENCE OF PRIOR REVISION. THERE IS NO FRACTURE OR DISLOCATION. SCREW FRAGMENTS ARE PRESENT WITHIN THE LATERAL ACETABULUM, WHICH IS DYSPLASTIC IN APPEARANCE. THIS COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED X-RAYS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 THE PATIENT WAS BORN WITH HIP DYSPLASIA. THE PATIENT¿S CUP STARTED TO WEAR AND WAS REVISED. ONE YEAR POST IMPLANTATION, THE PATIENT FELL, AND THE CUP WAS FOUND TO BE LOOSE. THE SURGEON RECOMMENDED A CUSTOM IMPLANT.

    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
    1634019 BONE SCR 6.5X40 SELF-TAP PROTHESIS, HIPS LPH ZIMMER MANUFACTURING B.V. N/A 63910872 00889024119840

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention| H SEE H10 NARRATIVE.