BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 12315461 · Received August 12, 2021

    Report

    Report Number
    1818910-2021-17760
    Event Type
    Injury
    Date Received
    August 12, 2021
    Date of Event
    January 1, 2020
    Report Date
    July 23, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). WHERE THE LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ARTICLE ENTITLED ¿RETENTION OF MONOBLOCK FEMORAL COMPONENTS USING A DUAL MOBILITY BEARING¿ WRITTEN MANISH KIRAN, MS, DNB, MCH, FRCS, AND VIJU PETER, MS, FRCS PUBLISHED BY THE BONE AND JOINT JOURNAL IN 2020 WAS REVIEWED. THE ARTICLES PURPOSE WAS TO PRESENT 3 CASES REVISED WITH DUAL MOBILITY SOCKET CEMENTED INTO THE ACETABULAR RECONSTRUCTION CUP, AND POLYETHYLENE BALL INSERTED IN SITU ONTO THE HEAD OF THE RETAINED WELL-FIXED MONOBLOCK STEM. ADVERSE EVENTS: CASE #1: (B)(6) YEAR-OLD MALE WITH A CHARNLEY STEM AND OGEE POLYETHYLENE CUP (UNKNOWN CEMENT). PATIENT UNDERWENT A REVISION FOR A LOOSE CUP (LOOSENING INTERFACE UNKNOWN). STEM WAS NOTED TO BE WELL-FIXED, NO OSTEOLYSIS OR INFECTION. CASE #2: (B)(6) YEAR-OLD FEMALE PRESENTED WITH PAIN AFTER HAVING A CHARNLEY STEM AND OGEE CUP (UNKNOWN CEMENT) IMPLANTED FOR 14 YEARS. SHE STRUGGLED WITH WALKING AND WAS FOUND TO HAVE A LOOSE CUP (LOOSENING INTERFACE UNKNOWN) AND OSTEOLYSIS. STEM WAS FOUND TO BE WELL FIXED. CASE #3: (B)(6) YEAR-OLD FEMALE PRESENTED WITH DIFFICULTY WALKING AND PAIN AFTER HAVING A CHARNLEY STEM AND OGEE CUP (CEMENT UNKNOWN) IMPLANTED FOR 14 YEARS. STEM WAS FOUND TO BE WELL FIXED. THERE WAS OSTEOLYSIS AND THE CUP WAS ALSO LOOSE (LOOSENING INTERFACE UNKNOWN). ALL PATIENTS HAD A DUAL MOBILITY CUP CEMENTED IN AT THE REVISION. NO COMPLICATIONS WERE NOTED DURING THE FOLLOW UP PERIOD FOR ANY OF THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211855 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention