BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 8898270 · Received August 15, 2019

    Report

    Report Number
    1818910-2019-101257
    Event Type
    Injury
    Date Received
    August 15, 2019
    Report Date
    August 5, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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. 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 CODE(S) 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. CORRECTIVE ACTION WAS NOT INDICATED. 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.

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED ENTITLED "CATASTROPHIC CERAMIC LINER FAILURE-THE SUBTLE SIGNS OF A NON-ENGAGED CERAMIC LINER." LITERATURE ARTICLE ENTITLED, ¿CATASTROPHIC LINER FAILURE-THE SUBTLE SIGNS OF A NON-ENGAGED CERAMIC LINER,¿ BY A. WALLS, A. TUCKER, D. S. WARNOCK, AND D. BEVERLAND (2018) IN THE JOURNAL OF ORTHOPAEDICS VOL. 15 PP. 363-365 WAS REVIEWED FOR MDR REPORTABILITY. THIS ARTICLE IS A CASE STUDY OF THA REVISION SURGERY FOLLOWING CERAMIC LINER FRACTURE DUE TO IMPINGEMENT OF THE LINER. THE FEMALE PATIENT UNDERWENT PRIMARY RIGHT CEMENTLESS TOTAL HIP REPLACEMENT WITH A TRI-LOCK 1 STANDARD STEM WITH A 48 MM PINNACLE (DEPUY SYNTHES, LEEDS, GBR) ACETABULAR CUP, A 4TH GENERATION BIOLOX DELTA CERAMIC FEMORAL HEAD (32MM +5.0) AND 32MM LINER (CERAMTEC GMBH, GER) COCR FEMORAL HEAD. ONE YEAR POSTOPERATIVELY, SHE PRESENTED WITH PAIN AND AN AUDIBLE SQUEAK IN HER HIP. INFECTION WAS RULED OUT AND NO FURTHER MEDICAL INTERVENTION WAS NEEDED. 16 MONTHS LATER, SHE PRESENTED WITH ACUTE PAIN AND AN AUDIBLE CRUNCHING SENSATION IN THE HIP. INTRAOPERATIVE FINDINGS REVEALED THE CERAMIC LINER IN MULTIPLE FRAGMENTS, DISSOCIATED FROM THE CUP AND THE CERAMIC HEAD WAS INTACT WITH GROSS STRIPE WEAR CAUSED BY THE FRACTURED CERAMIC LINER. THE EXPLANTED LINER WAS FRACTURED DUE TO IMPINGEMENT ON THE LINER. THE CERAMIC LINER WAS EXCHANGED FOR A POLYETHYLENE LINER AND A NEW CERAMIC HEAD (COP). THE ACETABULAR CUP AND TRI-LOCK STEM WERE LEFT IN SITU WITH NO APPARENT DAMAGE OR LOOSENING. THIS RESEARCH WAS DONE IN IRL. THE CONTACT INFORMATION IS (B)(6). PT IDENTIFIERS: FEMALE. ADVERSE EVENT(S) RELATED TO PRODUCT(S): IMPLANT NOISE: AUDIBLE SOUND (HEAD, CUP, AND LINER). IMPLANT FRACTURE POST-OP: CERAMIC LINER. IMPLANT DISSOCIATION: LOCKING MECHANISM (CUP AND LINER). IMPLANT BEARING WEAR: CERAMIC (HEAD). PATIENT(S) REPORTED HARM(S) PRIOR TO PROCEDURE: PAIN. SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690819 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention