BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 9029822 · Received September 13, 2019

    Report

    Report Number
    1818910-2019-104383
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    December 9, 2016
    Report Date
    August 27, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. POST MARKET SURVEILLANCE IS PER SEP 419. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (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

    LITERATURE ARTICLE RECEIVED ENTITLED "COMPARISON OF POLYETHYLENE WEAR BEFORE AND AFTER HIP REVISION WITH LINER EXCHANGE FIXED WITH THE ORIGINAL LOCKING MECHANISM." LITERATURE ARTICLE ENTITLED, ¿COMPARISON OF POLYETHYLENE WEAR BEFORE AND AFTER HIP REVISION WITH LINER EXCHANGE FIXED WITH THE ORIGINAL LOCKING MECHANISM¿ BY XINFENG GU, ET AL, PUBLISHED BY PLOS ONE (2016), VOL. 11, NO. 12, DOI:10.1371/JOURNAL.PONE.0167607 WAS REVIEWED FOR MDR REPORTABILITY. THE PURPOSE OF THIS ARTICLE WAS TO COMPARE THE WEAR OF CONVENTIONAL ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE (CUHMWPE) AND HIGHLY CROSS-LINKED POLYETHYLENE (HCLPE) IN HIP REVISION WITH LINER EXCHANGE FIXED WITH ORIGINAL LOCKING MECHANISM USING ANALYSIS OF HISTORY MEDICAL DATA. FROM JAN. 1, 2000, TO DEC. 31, 2007, 26 PATIENTS (WITH 29 INVOLVED HIPS) UNDERWENT LINER EXCHANGE REVISION FIXED WITH THE ORIGINAL LOCKING MECHANISM DUE TO WEAR OF CUHMWPE AND/OR OSTEOLYSIS. THE MEAN AGE WAS 53 ± 9 YEARS AT THE TIME OF THE PRIMARY TOTAL HIP ARTHROPLASTY (THA) AND 64 ± 9 YEARS AT THE REVISION. THE EXCHANGED LINERS (MARATHON, DEPUY) WERE MADE OF HCLPE. ANNUAL X-RAYS WERE USED TO MEASURE LINEAR WEAR AND OSTEOLYSIS. IN THE PRESENT STUDY, REVISIONS WITH ISOLATED HCLPE LINER (ALL WITH MARATHON, DEPUY) EXCHANGE THAT HAD THE SAME HIP BALL DIAMETER (28 MM) AND WERE FIXED WITH THE ORIGINAL LOCKING MECHANISM WERE FOLLOWED UP. WE WANTED TO COMPARE THE LINEAR PENETRATION RATES OF POLYETHYLENE BEFORE (CUHMWPE) AND AFTER (HCLPE) ISOLATED LINER EXCHANGE IN PATIENTS WHO UNDERWENT THA REVISION. THE REUSE OF LOCKING MECHANISM WAS ALSO STUDIED. IN ALL CASES, THE PRIMARY THA WAS PERFORMED VIA A POSTEROLATERAL APPROACH BETWEEN APR. 17, 1989, AND SEP. 1, 1994. ETIOLOGIES FOR PRIMARY THA WERE AS FOLLOWS: AVASCULAR NECROSIS (23 HIPS), OSTEOARTHRITIS (4 HIPS), AND ANKYLOSING SPONDYLITIS (2 HIPS). ON THE ACETABULUM SIDE, A CEMENTLESS, TITANIUM, POROUS-COATED SHELL (DUROLOC1, DEPUY) WITH A CUHMWPE LINER (ENDURON1, DEPUY) WAS USED WITH A PRESS-FIT TECHNIQUE. FOR THE FEMORAL COMPONENT, A CEMENTLESS, TAPERED, PROXIMALLY TITANIUM FIBER METAL AND HYDROXYAPATITE-COATED STEM (AML1, DEPUY) WAS USED. ALL HEADS THAT MADE OF COBALT-CHROMIUM ALLOY WERE 28 MM IN DIAMETER. CLINICAL AND RADIOGRAPHIC EVALUATIONS WERE ROUTINELY PERFORMED PREOPERATIVELY; AT 6 WEEKS, 3 MONTHS, 6 MONTHS, AND 1 YEAR POSTOPERATIVELY; AND ANNUALLY THEREAFTER. THE MEAN AGE AT REVISION WAS 63±9 YEARS. THE MEAN TIME INTERVAL BETWEEN THE PRIMARY AND REVISION THA WAS 11±2 YEARS. THE REASON FOR REVISION WAS POLYETHYLENE WEAR AND OSTEOLYSIS. ALL THE PATIENTS WITH CUHMWPE LINERS SHOWED OSTEOLYSIS ON THE RADIOGRAPHS BEFORE REVISION. HHS WAS ALSO IMPROVED FROM 71±6 POINTS BEFORE REVISION TO 81±7 POINTS 1-YEAR POST REVISION. NO ONE WAS LOST TO FOLLOW UP. THE MEAN PENETRATION OF THE CUHMWPE AND HCLPE LINERS OCCURRED IN THE FIRST YEAR WERE 0.44±0.28 MM (RANGE, 0.16 TO 1.1 MM) AND 0.38±0.35 MM (RANGE, 0.16 TO 0.64 MM), RESPECTIVELY. THE MEAN ANNUAL LINEAR PENETRATION RATES OF THE CUHMWPE AND HCLPE FROM THE SECOND YEAR ONWARD WERE 0.29±0.09 MM PER YEAR AND 0.08 ± 0.03 MM PER YEAR, RESPECTIVELY. DURING A MEAN OF 8 ±2 YEARS FOLLOW-UP AFTER REVISION, NO RE-REVISION WAS DONE FOR ANY REASON AND NO LOCKING MECHANICAL FAILURE WAS INDICATED. ONE PATIENT SUFFERED A HIP DISLOCATION TREATED WITH CLOSED REDUCTION SUCCESSFULLY APPROXIMATE ONE MONTH AFTER REVISION. NO PERIPROSTHETIC INFECTION OCCURRED. NO HCLPE PATIENTS SHOWED OSTEOLYSIS AT THE END OF THE FOLLOW-UP PERIOD. THE RESULTS SHOWED NO LOCKING MECHANISM FAILURE, NO ACETABULAR LOOSENING, AND NO OSTEOLYSIS. THE AUTHORS SUGGEST THAT THE ORIGINAL LOCKING MECHANISM SHOULD BE USED DURING ISOLATED LINER EXCHANGE REVISION IF IT IS INTACT AND IF THE CORRESPONDING HCLPE LINER IS AVAILABLE. THE AUTHORS DID NOT SPECIFY THE LOCATION OF THE OSTEOLYSIS DURING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823772 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS LZO DEPUY ORTHOPAEDICS, INC. 1818910

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R