BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 9981105 · Received April 21, 2020

    Report

    Report Number
    1818910-2020-11039
    Event Type
    Injury
    Date Received
    April 21, 2020
    Report Date
    April 13, 2020
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LPH
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H6 PATIENT CODE: NO CODE AVAILABLE (3191) USED TO CAPTURE THE GENERAL SYMPTOM OR INSUFFICIENT INFORMATION. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS HIP REPLACEMENT PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET AND THE PRODUCT CODES ARE NOW CONSIDERED INACTIVE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED ¿ORTHOPAEDIC REGISTRIES: THE AUSTRALIAN EXPERIENCE¿, WRITTEN BY RICHARD N. DE STEIGER, ET AL, PUBLISHED IN EFFORT OPEN REV 2019; 4 DOI: 10.1302/2058-5241.4.180071, WAS REVIEWED. THE PURPOSE OF THE ARTICLE WAS TO DEFINE, IMPROVE AND MAINTAIN THE QUALITY OF CARE FOR INDIVIDUALS RECEIVING JOINT REPLACEMENT SURGERY. THE DATA WAS SUBMITTED BY HOSPITALS. INFORMATION INCLUDES, BUT IS NOT LIMITED TO AGE, DATE AND SIDE OF SURGERY, SURGEON, TYPE OF PROSTHESIS INSERTED, PATIENT DIAGNOSIS, METHODS OF IMPLANT FIXATION, AND OTHER INFORMATION ASSOCIATED WITH THE OPERATION. DEPUY PRODUCTS USED: LCS, PFC SIGMA (KNEES); ASR (HIP) THE DATA WAS COLLECTED FROM 1 SEPTEMBER 1999 THROUGH 2017. THE REGISTRY HAS REPORTED ON MANY CLASSES OF PROTHESIS AND THEIR OUTCOMES. ALL DATA IS COMPILED IN TABLE 1¿CUMULATIVE PERCENTAGE REVISION OF PRIMARY TOTAL KNEE REPLACEMENT COMBINATIONS WITH 15-YEAR DATA REGISTRY. ONLY PROSTHESES WITH OVER 350 PROCEDURES WERE LISTED. FIGURE 1 IS A FUNNEL PLOT OF PRIMARY TOTAL CONVENTIONAL HIP REPLACEMENT (EXCLUDING LARGE-HEAD METAL-ON-METAL, ALL DIAGNOSES, REVISION FOR PROSTHESIS DISLOCATION WITHIN 2 YEARS). FIGURE 2 SHOWS THE USE OF METAL-ON-METAL TOTAL CONVENTIONAL HIP REPLACEMENT BY HEAD SIZE OVER TIME. NO INFORMATION IS GIVEN REGARDING SURGICAL PROCEDURES OR CEMENT USED. IN 2007 THE REGISTRY WAS THE FIRST BODY TO IDENTIFY A SIGNIFICANTLY HIGHER RATE OF REVISION FOR THE ASR HIP RESURFACING SYSTEM AND THE FOLLOWING YEAR THE ASR XL ACETABULAR SYSTEM. THE IDENTIFICATION OF THESE PARTICULAR PROSTHESIS WAS ASSOCIATED WITH A SUBSTANTIAL REDUCTION IN THEIR USE BY SURGEONS AND THE SUBSEQUENT WITHDRAWAL OF THESE PROSTHESES FROM THE AUSTRALIAN MARKET IN DECEMBER 2009. THIS LED TO A FURTHER EXAMINATION OF ALL PROSTHESES THAT HAD A LARGE-HEAD METAL-ON-METAL BEARING. THIS CLASS OF LARGE-HEAD METAL-ON-METAL DEVICES WAS INTRODUCED WITH LITTLE CLINICAL DATA AND WAS EMPLOYED TOADDRESS SEVERAL FACTORS. THESE INCLUDED REVISION OF RESURFACING HIP ARTHROPLASTY DUE TO FRACTURE TO AVOID REVISING THE ACETABULUM, TO REDUCE REVISION FOR WEAR-RELATED ISSUES AS METAL-ON-METAL BEARINGS HAD REPORTEDLY LOW-WEAR CHARACTERISTICS, AND TO USE LARGE-DIAMETER FEMORAL HEADS TO REDUCE THE RISK OF HIP DISLOCATION. A MORE DETAILED ANALYSIS WAS PERFORMED THE FOLLOWING YEAR. THERE WERE 12 COMBINATIONS THAT MET THOSE REQUIREMENTS AND HAD A HIGHER REVISION RATE FOR LOOSENING AND OSTEOLYSIS IN METAL-ON METAL AND IT WAS NOT JUST THE ASR HIP. REVISIONS PER IMPLANT ARE WITHIN THE TABLE BASED UPON REVISIONS OF EITHER FEMORAL COMPONENT, TIBIAL COMPONENT, TKR OR OTHER. NO SYMPTOMS OR OTHER INFORMATION ARE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446930 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP LPH DEPUY INTERNATIONAL LTD - 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention