BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA PROTR.LINER ØINT 36MM #L

    MDR report key: 9544829 · Received January 3, 2020

    Report

    Report Number
    3008021110-2019-00153
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    December 18, 2019
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHRS CHECK: BY CHECKING THE DHRS, NO ANOMALY WAS FOUND ON THE LINERS PLACED ON THE MARKET WITH LOT# 1819777 STER. 1900030. MOREOVER, ACCORDING TO OUR RECORDS, AT LEAST 42 LINERS WITH THE SAME PRODUCTION AND STERILIZATION LOT# (OUT OF 50 MANUFACTURED) HAVE ALREADY BEEN IMPLANTED, WITHOUT RECEIVING ADDITIONAL COMPLAINTS ON THEM. EXPLANT ANALYSIS: EXPLANTS WERE NOT RETUNED TO LIMA CORPORATE. SOME PICTURES OF THE COMPONENTS WERE RECEIVED, WHERE WE COULD NOTE THAT THE POLY LINER HAD BEEN DAMAGED BY A SCREW (WE CAN SUPPOSE IT HAPPENED INTRA-OPERATIVELY, MAYBE DUE TO THE USE OF THE SCREW TO HELP REMOVING THE LINER ITSELF). X-RAYS ANALYSIS: X-RAYS WERE NOT AVAILABLE TO BE PROVIDED TO LIMA CORPORATE. CONCLUSION: VERY FEW INFORMATION AVAILABLE ON THIS CASE, EVEN IF WE REPEATEDLY ASKED TO THE COMPLAINT SOURCE, THE FOLLOWING INFORMATION WAS NEVER PROVIDED TO US (THE LIMA PERSON RESPONSIBLE FOR THIS CASE LEFT THE COMPANY, MAKING IT IMPOSSIBLE TO GATHER THE MISSING DETAILS): PRE-OPERATIVE X-RAYS REFERRING TO REVISION SURGERY; CODE AND LOT#S OF THE COMPONENTS IMPLANTED ON (B)(6) 2019; - GERM RESPONSIBLE FOR THE INFECTION; CAUSE FOR PREVIOUS REVISION SURGERY; PATIENT DATA. WITH THE VERY FEW INFORMATION AVAILABLE, NO DEFINITIVE CONCLUSION CAN BE DRAWN ON THE CAUSE FOR THE REPORTED "METALLOSIS"/INFECTION. HOWEVER, THE ABSENCE OF DEVIATION DETECTED BY THE CHECK OF THE MANUFACTURING AND STERILIZATION CHARTS OF THE LINER, CONFIRMS THAT THE COMPONENT WAS MANUFACTURED UP TO SPECIFICATIONS AND REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THIS EVENT CANNOT BE CLASSIFIED AS PRODUCT RELATED. PMS DATA: (B)(4). NO SPECIFIC ACTION FOR THIS CASE. LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO "METALLOSIS" AND INFECTION PERFORMED ON (B)(6) 2019. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2019 AND WAS A REVISION SURGERY OF A COMPETITOR'S IMPLANT. DURING REVISION SURGERY, THE SURGEON REMOVED THE LINER (CODE 5886.51.260 LOT 1819777 STER. 1900030), THE HEAD AND THE ADAPTOR (NON LIMA). THE ACETABULAR CUP WAS NOT REPLACED. THE INFECTION WAS CLEANED AND TREATED WITH ANTIBIOTICS. PATIENT DATA: MALE. NO FURTHER INFORMATION AVAILABLE. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHRS OF THE LOT# INVOLVED, NO ANOMALY WAS FOUND ON THE LINERS PLACED ON THE MARKET WITH LOT# 1819777. WE WILL SUBMIT A FINAL MDR AFTER THE FINAL INVESTIGATION.

    Description of Event or Problem · 1

    HIP REVISION SURGERY DUE TO METALOSIS AND INFECTION PERFORMED ON THE (B)(6) 2019. PREVIOUS SURGERY TOOK PLACE ON THE (B)(6) 2019. DURING REVISION SURGERY, THE SURGEON REMOVED THE LINER (CODE 5886.51.260, LOT 1819777, STER. 1900030), THE HEAD AND ADAPTER (NON LIMA). INFECTION WAS CLEANED AND TREATED WITH ANTIBIOTICS. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5352 DELTA PROTR.LINER ØINT 36MM #L PROTRUDED LINERS (UHMWPE X-LIMA + TI6AL4V) I.D. 36MM - SIZE LARGE LPH LIMACORPORATE S.P.A. 5886.51.260 1819777

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention