BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI MULTIHOLE 60MM G

    MDR report key: 17861926 · Received October 3, 2023

    Report

    Report Number
    0001825034-2023-02296
    Event Type
    Injury
    Date Received
    October 3, 2023
    Date of Event
    February 3, 2022
    Report Date
    January 18, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00887868356063
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: SOUTH AFRICA. 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. D10: 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 02828; 0001825034 - 2023 - 02829; 0001825034 - 2023 - 02830.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: A2, A3, A4, B3, B5, B7, G3, G6, H2, H6 NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. UNABLE TO CONFIRM COMPLAINT. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES: IMPRESSIONS: 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 DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT IS CONFIRMED VIA XRAY. 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 UNDERWENT A LEFT HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT FOR AN UNKNOWN REASON. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS BORN WITH HIP DYSPLASIA. THE PATIENTS CUP STARTED TO WEAR AND WAS REVISED. THE PATIENT FELL ONE YEAR POST IMPLANTATION AND IT WAS FOUND THAT THE PATIENT'S CUP WAS LOOSE. IT WAS RECOMMENDED THE PATIENT WAIT FOR 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
    1632786 G7 OSSEOTI MULTIHOLE 60MM G PROTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A 7024727 00887868356063
    1761350 G7 OSSEOTI MULTIHOLE 60MM G PROTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A 7024727 00887868356063

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention| H