BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 50D

    MDR report key: 9943284 · Received April 9, 2020

    Report

    Report Number
    0001825034-2020-01505
    Event Type
    Injury
    Date Received
    April 9, 2020
    Date of Event
    March 1, 2019
    Report Date
    July 28, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: UPDATED: D4; G4; H2; H3; H4; H6. REPORTED EVENT WAS CONFIRMED VIA MEDICAL RECORDS/RADIOGRAPHS REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: (SUMMARIZED BY HCP), INCREASED PAIN DUE TO WORSENING RIGHT HIP OA (CONTRALATERAL SIDE), RIGHT HIP THA PERFORMED ON AN UNKNOWN DATE. AT ONE-YEAR FOLLOW-UP, REGULARLY PARTICIPATES IN MODERATE ACTIVITIES, VERY SATISFIED. OCCASIONAL MILD HIP PAIN, DAILY NSAIDS, NO ABNORMALITIES ON X-RAY. LEFT HIP ILIOPSOAS TENDINITIS, ONSET, TOLERATED, MEDROL DOSE PACK PRESCRIBED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT. 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

    NO ADDITIONAL INFORMATION ON REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000856- G7 NEUTRAL E1 LINER 36MM D-6025178, 193108- ECHO B-MTRC MP FP HO 8-66931OR, 650-1057-CER BIOLOXD OPTION HD 36MM-2904536. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEFT ILIOPSOAS TENDINITIS, REQUIRING AN ORAL STEROID TREATMENT 1-YEAR POST IMPLANTATION. NO FURTHER INTERVENTION HAS BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406006 G7 PPS LTD ACET SHELL 50D PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6149828

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10.