BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1818910-2019-103484

    MDR report key: 8974415 · Received September 9, 2019

    Report

    Report Number
    1818910-2019-103484
    Event Type
    Injury
    Date Received
    September 9, 2019
    Date of Event
    August 27, 2009
    Report Date
    August 19, 2019
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. WWCAPA (B)(4) SUPERSEDED BY MDD CAPA-(B)(4). PREVIOUS INVESTIGATIONS THAT HAVE INCLUDED DEVICE HISTORY REVIEWS SINCE THE ASR PLATFORM WAS LAUNCHED HAVE SHOWN NO INDICATION OF DEVIATIONS OR ANOMALIES WITH REGARD TO MATERIAL, MANUFACTURING OR INSPECTION. THEREFORE NO DHR (DEVICE HISTORY RECORD) REVIEW FOR THIS INDIVIDUAL ASR COMPONENT WILL BE CARRIED OUT AT THIS POINT IN TIME. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. WWCAPA (B)(4) SUPERSEDED BY MDD CAPA-(B)(4) HAS BEEN ESTABLISHED REGARDING ROOT CAUSE AND/OR CORRECTIVE ACTIONS. FURTHER DETERMINATIONS AND ACTIONS WILL BE DOCUMENTED IN THE CORRECTIVE AND PREVENTATIVE ACTION INVESTIGATION AS APPROPRIATE. (B)(4).   : 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

    EARLY FAILURE OF METAL-ON-METAL BEARINGS IN HIP RESURFACING AND LARGE-DIAMETER TOTAL HIP REPLACEMENT A CONSEQUENCE OF EXCESS WEAR BY D.J. LANGTON, S.S. JAMESON, T.J. JOYCE, N.J. HALLAB, S. NATU, AND A.V.F. NARGOL PUBLISHED BY THE JOURNAL OF BONE & JOINT SURGERY ON 27 AUGUST 2009. THE ARTICLE'S PURPOSE: "WE SOUGHT TO ESTABLISH THE RATE OF FAILURE SECONDARY TO ADVERSE REACTIONS TO METAL DEBRIS (ARMD) IN OUR PATIENTS, TO IDENTIFY RELATIONSHIPS BETWEEN THIS MODE OF FAILURE AND THE WEAR RATE OF THE PROSTHETIC JOINT, AND TO PROVIDE A POTENTIAL EXPLANATION FOR THE INCREASED INCIDENCE OF THIS IN WOMEN. FOR THE PURPOSES OF THIS PAPER WE THEREFORE USE THE ACRONYM ¿ARMD¿ AS AN UMBRELLA TERM TO DESCRIBE JOINT FAILURES ASSOCIATED WITH PAIN, A LARGE STERILE EFFUSION OF THE HIP AND/OR MACROSCOPIC NECROSIS/METALLOSIS." THE STUDY WAS OF 505 ASR DEVICES (87 OF THOSE WERE THRS) AND 155 BHRS FROM 2002 TO 2009(BHRS WERE FROM 2002 TO APRIL 2004 AND ASR WAS USED THERE AFTER). TABLE III LISTS 17 CASES OF REVISION WITH PATIENT IDENTIFIERS CAPTURED IN LINKED COMPLAINTS LISTING DESCRIPTIVE FINDINGS OF ARMD. ADDITIONALLY, TABLE IV INCLUDED DATA FROM OTHER ASR REVISION CASES WITHOUT PATIENT IDENTIFIERS WITH REASONS OF REVISION AS PAIN, EFFUSION, PSEUDOTUMOR AND FRACTURE (ANATOMICAL LOCATION NOT GIVEN). IT IS NOTED THAT CHROMIUM LEVELS WERE IN THE RANGE OF 3.89 TO 41.8 AND COBALT 7.82 TO 99.1 FOR THE PATIENTS IN THIS STUDY. FOR HISTOPATHOLOGICAL EXAMINATION OF TISSUES FROM REVISION PROCEDURES OF THE 17 IDENTIFIABLE CASES: "THE VARIOUS LAYERS OF THE NEOCAPSULE WERE STUDIED. LAYER 1 CONSISTS OF THE SURFACE MEMBRANE AND WAS GRADED AS TYPE 1 TO 4.17 TYPE 1 SURFACES HAVE AN INTACT PSEUDOSYNOVIAL MEMBRANE. TYPE 2 SURFACES SHOW A LOSS OF THE PSEUDOSYNOVIAL MEMBRANE. TYPE 3 SURFACES ARE ASSOCIATED WITH FIBRIN DEPOSITION IN ADDITION TO THE LOSS OF THE SURFACE MEMBRANE, AND IN TYPE 4 THERE IS GROSS DISRUPTION OF THE SURFACE MEMBRANE WITH FIBRIN DEPOSITION AND FISSURING. LAYER 2 IS THE SUBSYNOVIAL LAYER, WHICH USUALLY CONTAINS THE INFLAMMATORY INFILTRATE. LAYER 3 IS THE VASCULAR LAYER, WHICH CONTAINS THE ERIVASCULAR LYMPHOCYTE CUFFING. LAYER 4 IS THE DEEPER LAYERS CONTAINING MUSCLE FAT AND FIBROUS TISSUE. THE THICKNESS OF THE HISTIOCYTE BAND CONTAINING PARTICULATE MATTER IN LAYER 2 WAS MEASURED USING THE GRATICULE. THE PRESENCE OF PERIVASCULAR LYMPHOCYTIC CUFFING AND ITS AVERAGE THICKNESS IN LAYER 3 WAS ALSO RECORDED." IMPACTED PRODUCTS: ASR & ASR XL. ADVERSE EVENTS: SURGICAL INTERVENTION, FOREIGN BODY REACTION, SOFT TISSUE NECROSIS, PAIN, HYPERSENSITIVITY, BLOOD HEAVY METAL INCREASED. CASE 2 FEMALE EXPERIENCE ONSET OF PAIN 3 MONTHS POST INITIAL SURGERY AND REVISION FROM ONSET OF PAIN WAS 33 MONTHS. REVISION RESULTS: LAYER 1 - TYPE 4; LAYER 2 HISTOCYTE SHEET THICKNESS (MM) - .5; LYMPHOCYTES: MARKED; LAYER 3 LYMPHOCYTE CUFF THICKNESS (MM) .2 TO .25; COMMENTS: LYMPHOCYTIC CUFFS HAVE OCCASIONAL GERMINAL CENTRES.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R