BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, ø 32/+7, TAPER 12/14

    MDR report key: 18267956 · Received December 5, 2023

    Report

    Report Number
    0009613350-2023-00673
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    November 8, 2023
    Report Date
    February 15, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    K192416
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10. -SHELL POROUS WITH CLUSTER HOLES 48 MM ITEM#00620204822 LOT#07876013. -WAGNER SL REVISION® HIP STEM, UNCEMENTED, ø 14/190, TAPER 12/14 ITEM#0100101914 LOT#3011183. -ARCOS 12X190MM SPL TPR DIST ITEM#11300912 LOT#232160. -EXTENDED 4 HOLE GTR W/4 CABLES ITEM#00223200206 LOT#56694392. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICE IS USED FOR TREATMENT. THE REPORTED PRODUCT AND THE CONCOMITANT PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS SUCH AS THE SURGICAL REPORT FOR IMPLANTATION AND REVISION SURGERY WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED THE FOLLOWING: 02-NOV-2023. ¿ FOLLOW UP POST CLOSED REDUCTION FROM DISLOCATION ON 24-AUG-2023 AT LOVELACE. ¿ PRIOR DISLOCATION WITH REDUCTION LAST MONTH AT LOVELACE WESTSIDE ER. ¿ NO PAIN. ¿ RIGHT HIP UNILAT W/AP PELVIS (3V) X-RAYS: WELL REDUCED RIGHT THA REVISION. ¿ PLAN FOR REVISION. ¿ I HAVE RECOMMENDED A CONSTRAINED LINER DUE TO THE FORESHORTENING PRESENT. PRIOR TO THE RIGHT THA 2022 REVISION THA. THIS RESULTED IN INADEQUATE LENGTH RESTORATION AND LOSS OF ABDUCTOR TENSION FROM THE PREVIOUS ISSUES¿ ¿ DOES NOT RECOMMEND REVISION OF ACETABULAR SHELL DUE TO BONE LOSS AND POTENTIAL FOR MORE RISK (B)(6) 2023. ¿ PRE-OP/POST-OP DX: INSTABILITY ¿ EBL 200ML ¿ ¿ I FELT THAT DUE TO HER FORESHORTENING THAT WAS SIGNIFICANT AND CHRONIC SHE IS HAVING ABDUCTOR DYSFUNCTION¿ ¿ BOTH DISLOCATIONS WERE ANTERIOR. ¿ SPINAL ANESTHESIA. ¿ PREVIOUS HIP INCISION WAS UTILIZED BUT NOT ENTIRELY. ¿ PREVIOUS TROCHANTERIC PLATE INTACT. ¿ PROXIMAL CABLE REMOVED AS IT WAS FRAYING. ¿ TROCHANTERIC NON-UNION BUT DID NOT FEEL THAT TRYING TO REPAIR THE NON-UNION WOULD BE MUCH BENEFIT. ¿ COULD NOT GET THE HIP TO DISLOCATE POSTERIORLY. EXAMINED TROCHANTER AND IT APPEARED AS THIS WAS IMPINGING UP AGAINST THE ILIUM SUPERIORLY TO THE ACETABULAR COMPONENT CAUSING LEVERING OUT. ANTERIORLY, CAUSING THESE ANTERIOR DISLOCATIONS. HIP DISLOCATED WITH BONE HOOK POSTERIORLY ¿ ¿I FELT THAT THE CUP WAS IN APPROPRIATE POSITION AND I ALSO FELT THAT THE STEM WAS ABOUT 20 TO 25. DEGREES ANTEVERSION AND THIS WAS WELL FIXED WHEN IT WAS CHECKED¿ ¿ ACETABULAR COMPONENT WAS NOTED TO BE COMPETENT. ¿ CEMENTED LINER. ¿ NO INTRA-OP EVENTS. 3 RADIOGRAPHS WERE REVIEWED BY THE HEALTH CARE PROFESSIONAL AND NOT SUBMITTED TO RADIOLOGISTS, AS THERE IS SUFFICIENT DOCUMENTATION OF IMPRESSION CONTAINED WITHIN THE MEDICAL RECORDS. A SUBMISSION OF THE IMAGES WOULD NOT ENHANCE THE INVESTIGATION. IT IS POSSIBLE THAT THE RECURRENT DISLOCATIONS ARE RELATED TO THE PATIENT CONDITION AS REPORTED IN THE RECEIVED MEDICAL DOCUMENTS. HOWEVER, WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. NO CORRECTIVE, PREVENTIVE OR FIELD ACTION WAS TAKEN FOLLOWING THE INVESTIGATION OF THIS EVENT. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10. LINER STANDARD 32 MM I.D. FOR USE WITH 48 MM O.D. SHELL ITEM#00630504832 LOT#65039055 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT POST IMPLANTATION, PATIENT UNDERWENT A FIRST REVISION SURGERY IN (B)(6) 2022 DUE TO ASEPTIC LOOSENING. APPROXIMATELY 11 MONTHS LATER, UNDERWENT ANOTHER REVISION SURGERY DUE TO RECURRENT DISLOCATIONS. 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
    2158942 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, ø 32/+7, TAPER 12/14 PROSTHESIS, HIP LZO ZIMMER GMBH N/A 2724106

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Hospitalization| R