BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CDH STEM

    MDR report key: 21737308 · Received April 1, 2025

    Report

    Report Number
    3002806535-2025-00138
    Event Type
    Injury
    Date Received
    April 1, 2025
    Report Date
    May 2, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S PRODUCT NUMBER IS UNKNOWN. G2 ¿ FOREIGN ¿ TURKEY. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K030055. AUTHOR, TURGUT N., ERDEM M.& ERDEM A.C. IS STEP-CUT SHORTENING OSTEOTOMY A BETTER CHOICE THAN TRANSVERSE OSTEOTOMY FOR TOTAL HIP ARTHROPLASTY FOR CROWE TYPE III-IV HIP DYSPLASIA? ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH, 110 (6), OCTOBER 2024, 103883. HTTPS://DOI.ORG/10.1016/J.OTSR.2024.103883. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO THE MISSING LOT NUMBER. A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED DUE TO MISSING REFERENCES AND LOT NUMBERS. A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. 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

    THE JOURNAL ARTICLE REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY USING A STEP-CUT OSTEOTOMY. SUBSEQUENTLY, DEVELOPED FEMORAL NON-UNION AND AN ADDITIONAL PROCEDURE WAS PERFORMED USING A PLATING AND STRUT GRAFT. THE NON-UNION SITE UNITED BY 3.8 MONTHS. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    ON 14-MAR-2025, A RETROSPECTIVE JOURNAL ARTICLE WAS RETRIEVED FROM ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH (2024) THAT REPORTED A STUDY FROM TURKEY. THE PURPOSE OF THE STUDY WAS TO DEMONSTRATE WHETHER TRANSVERSE OR STEP-CUT OSTEOTOMY IS SUPERIOR IN HIPS WHO UNDERGO ARTHROPLASTY FOR HIGH RIDING HIP DYSPLASIA. THE STUDY REVIEWED THE CHALLENGES AND COMPLICATIONS ENCOUNTERED DURING 99 HIPS/90 PATIENTS (9 BILATERAL/81 UNILATERAL) (50 RIGHT/49 LEFT), CEMENTLESS TOTAL HIP ARTHROPLASTIES COMBINED WITH TRANSVERSE OR STEP-CUT SHORTENING OSTEOTOMIES PERFORMED FOR CROWE III (16) AND IV (83) DYSPLASTIC HIPS. THE SURGERIES WERE PERFORMED BETWEEN 2007-2019 USING A POSTEROLATERAL APPROACH IN 43 SURGERIES AND A DIRECT LATERAL HARDINGE APPROACH IN 56 SURGERIES. A PERCUTANEOUS ADDUCTOR TENOTOMY WAS PERFORMED TO RELEASE EXCESSIVE ADDUCTOR CONTRACTURE IN 21 CASES PRIOR TO POSITIONING THE PATIENT IN THE LATERAL DECUBITUS POSITION AND AN ILIOPSOAS TENOTOMY WAS ADDED IN 11 CASES. DR. DENIZ GULABI PERFORMED THE TRANSVERSE OSTEOTOMIES WHILE DR. MEHMET ERDEM AND DR. NECDET SAGLAM PERFORMED STEP-CUT OSTEOTOMIES. STEP-CUT OSTEOTOMY WAS PERFORMED IN 64 HIPS (35 CDH STEM, 29 WAGNER CONE STEM), TRANSVERSE IN 35 HIPS (22 CDH, 13 WAGNER CONE). ALL FEMORAL STEMS WERE CEMENTLESS, AND TWO TYPES OF FEMORAL STEMS WERE APPLIED BASED ON THE SURGEON¿S EXPERIENCE AND PREFERENCE: (I) PROXIMAL FIXATION STRAIGHT CDH STEMS (57) (CONGENITAL DYSPLASTIC HIP) AND (II) DIAPHYSEAL FIXATION CYLINDRICAL WAGNER CONE PROSTHESIS TM STEMS (42). ALL ACETABULUMS WERE IMPLANTED USING TRILOGY IT ACETABULAR SHELL AND WERE INSTALLED IN THE TRUE ACETABULUM WITH THE SUPPORT OF AUGMENTATION SCREWS. ACETABULAR CUP SIZE WAS A MEAN OF 46 MM AND HEAD SIZE WAS MOSTLY 28 AND 32 MM. THE BILATERAL HIP SURGERIES WERE STAGED WITH AT LEAST THREE MONTHS INTERVAL BETWEEN. THE STUDY POPULATION HAD A MEAN AGE OF 48.8 YEARS AT TIME OF SURGERY (RANGE, 21-79 YEARS); (11 MALES/79 FEMALES). FOLLOW-UP WAS A MINIMUM OF TWO YEARS AND WAS CONDUCTED AT [INSERT IF GIVEN: SIX WEEKS, SIX MONTHS, ONE YEAR AND ANNUALLY THEREAFTER] WITH A MEAN LENGTH OF FOLLOW-UP FOR 64.3 MONTHS (RANGE, 24-192 MONTHS). IT WAS REPORTED IN THE JOURNAL ARTICLE THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY USING A STEP-CUT OSTEOTOMY. SUBSEQUENTLY, DEVELOPED FEMORAL NON-UNION AND AN ADDITIONAL PROCEDURE WAS PERFORMED USING A PLATING AND STRUT GRAFT. THE NON-UNION SITE UNITED BY 3.8 MONTHS. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT. PLEASE REFERENCE JOURNAL ARTICLE: TURGUT N., ERDEM M.& ERDEM A.C. IS STEP-CUT SHORTENING OSTEOTOMY A BETTER CHOICE THAN TRANSVERSE OSTEOTOMY FOR TOTAL HIP ARTHROPLASTY FOR CROWE TYPE III-IV HIP DYSPLASIA. ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH, 110 (6), OCTOBER 2024, 103883. HTTPS://DOI.ORG/10.1016/J.OTSR.2024.103883.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933720 UNKNOWN CDH STEM HIP PROSTHESIS LPH BIOMET UK LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H SEE H10 NARRATIVE