BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 HI-WALL E1 LINER 32MM C

    MDR report key: 17470882 · Received August 7, 2023

    Report

    Report Number
    0001825034-2023-01825
    Event Type
    Injury
    Date Received
    August 7, 2023
    Date of Event
    July 12, 2023
    Report Date
    November 10, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304527010
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCT: 163670, 32MM MOD HEAD COCR +3MM NECK, (B)(6); 51-116140, TPRLC 133 MP TYPE1 BM SO 14,(B)(6); 010000701, G7 BONEMASTER LTD ACET SHL 48C, 7482911. REPORT SOURCE FOREIGN: AUSTRALIA . MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 01829. 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. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE HEAD/LINER/STEM LAYING IN A TUB WITH BLOOD ON IT. NO OTHER INFORMATION COULD BE OBTAINED FROM THE IMAGES. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO 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: RIGHT HIP ARTHROPLASTY DISLOCATION WITH ABNORMAL CUP ANTEVERSION AS NOTED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT IS CONFIRMED VIA PROVIDED XRAYS. 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 HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED TWELVE DAYS POST OP DUE TO DISLOCATION. PER SALES REP, THE VERSION OF THE ACETABULAR CUP WAS TOO ANTEVERTED AND THE ORIGINATION OF THE HIGHWALL LINER WAS CAUSING LEVERAGE MAKING THE FEMORAL HEAD DISLOCATE ANTERIORLY. SURGEON BELIEVES THE ORIGINATION OF THE CUP WAS FINE AND THAT IT WAS DUE TO A NON-COMPLIANT PATIENT. THE PATIENT HAD A SHUFFLE GAIT AND DID NOT WANT TO FOLLOW POST OPERATIVE PROTOCOL, PER SURGEON. THE STEM, HEAD, AND LINER WERE EXCHANGED. NO ALLEGATIONS AGAINST THE STEM AS IT WAS REMOVED BECAUSE THE SURGEON KNOCKED THE FEMORAL HEAD HARD DISLODGING THE STEM.

    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
    662395 G7 HI-WALL E1 LINER 32MM C PROTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6956867 00880304527010

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Prefer Not To Disclose Hospitalization| R SEE H10 NARRATIVE.