BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA-TT ACETAB.CUP 60 MM

    MDR report key: 10430687 · Received August 20, 2020

    Report

    Report Number
    3008021110-2020-00060
    Event Type
    Injury
    Date Received
    August 20, 2020
    Date of Event
    August 10, 2020
    Report Date
    April 9, 2021
    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

    BY CHECKING THE STERILIZATION CHARTS OF THE LIMA COMPONENTS INVOLVED, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE 6 DELTA CUPS BELONGING TO LOT# 1104520 - STER.1100134, ON THE 37 DELTA NEUTRAL LINERS BELONGING TO LOT# 1110450 - STER.1100312, AND ON THE 80 SCREWS BELONGING TO LOT# 1102262 - STER. 1100092. NO PRE-EXISTING ANOMALIES WERE DETECTED AS WELL ON THE 30 MODULAR HEADS BELONGING TO LOT# 1106900 - STER.1100216 AND ON THE 14 REVISION NECKS BELONGING TO LOT# 1006879 - STER.1000186. THEREFORE, WE CAN STATE ALL THE COMPONENTS HAVE BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAYS RECEIVED - DATED (B)(6) 2020 - HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "ON THE X-RAY THE IMPLANTS LOOK FINE WITHOUT CLEAR SIGNS OF LOOSENING. THE LUCENT LINE DISTALLY OF THE CUP MAY BE AN INDICATOR OF A LOW VIRULENT INFECTION SINCE IMPLANTATION BUT I BELIEVE THIS SHOULD BE MORE ADVANCED 9YRS AFTER IMPLANTATION. I SUCH CONCLUDE IT SEEMINGLY IS A CASE OF A "LATE" INFECTION. NOT UNUSUAL IN AN OLD PATIENT WITH MANY COMORBIDITIES. TREATING SUCH A CASE WITHIN 3 WEEKS AFTER ONSET OF INFECTION THERE IS A GOOD CHANCE OF RESOLVING IF AB TREATMENT MATCHES THE CAUSING PATHOGEN. LATER CHANCES ARE LOW. EXCHANGE OF CUP AND PROXIMAL NECK WITH USING AB LOADED CEMENT APPEARS AN ADEQUATE APPROACH, ESPECIALLY CONSIDERING THE HIGH RISK OF PROLONGED SURGERY. THE IMPLANTS THEMSELVES ARE NOT TO BE BLAMED. WE WOULD HAVE DONE SIMILARLY BUT WITHOUT USING CEMENT. INSTEAD, WE WOULD HAVE REPLACED THE CUP WITH ANOTHER DELTA TT + OSTEOMYCIN". STATING THAT: NO PRE-EXISTING ANOMALIES WERE FOUND ON THE STERILIZATION CHARTS OF THE INVOLVED PRODUCTS, THE MEDICAL CONSULTANT SUGGESTED THAT "THE LUCENT LINE DISTALLY OF THE CUP MAY BE AN INDICATOR OF A LOW VIRULENT INFECTION SINCE IMPLANTATION BUT I BELIEVE THIS SHOULD BE MORE ADVANCED 9YRS AFTER IMPLANTATION. I SUCH CONCLUDE IT SEEMINGLY IS A CASE OF A "LATE" INFECTION. NOT UNUSUAL IN AN OLD PATIENT WITH MANY COMORBIDITIES". WE CAN CONCLUDE THAT THE ROOT CAUSE ANALYSIS REVEALED THIS COMPLAINT TO BE MOSTLY PATIENT FACTOR RELATED. PMS DATA: BASED ON OUR PMS DATA, WE CAN ESTIMATE A REVISION RATE OF DELTA TT ACETABULAR CUPS BELONGING TO THE FAMILY 5552.15.XXX DUE TO INFECTION OF 0.017 %. NO SPECIFIC ACTION FOR THIS CASE. LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT. NOTE: THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINT SOURCE, X-RAY SHOWED LUCENCY AROUND THE INFERIOR PORTION OF THE ACETABULAR CUP. ACETABULAR COMPONENTS PREVIOUSLY IMPLANTED ON (B)(6) 2011: DELTA-TT ACETABULAR CUP, PRODUCT CODE 5552.15.600, LOT# 1104520 - STER.1100134. DELTA NEUTRAL LINER ØINT 36MM LARGE SIZE, PRODUCT CODE 5885.51.260, LOT# 1110450 - STER.1100312. BONE SCREW Ø6,5 H.35MM, PRODUCT CODE 8420.15.040, LOT# 1102262 - STER. 1100092 WERE EXPLANTED. IT WAS REPORTED THAT THE DELTA TT ACETABULAR CUP WAS REPLACED WITH A CEMENTED CUP AND THE CEMENT WAS MIXED WITH AN EXTRA DOSE OF ANTIBIOTICS TO COMBAT THE INFECTION. ALSO, THE COMPONENTS ON THE FEMUR: FEM. MODULAR HEAD - L Ø36MM, PRODUCT CODE 5010.09.363, LOT# 1106900 - STER.1100216 REVISION LATER. NECK H.70MM, PRODUCT CODE 7515.15.120, LOT# 1006879 - STER.1000186 WERE EXPLANTED AND REPLACED WITH THE SAME SIZE OPTIONS. ACCORDING TO THE REPORTED INFORMATION, SURGEON RESPONSIBLE FOR THE REVISION SURGERY EXPLAINED THAT THE PATIENT INVOLVED HAS MULTIPLE COMORBIDITIES, IS NOT A HEALTHY MAN AND IS IMMUNOSUPPRESSED. THE INFECTION TARGETED OTHER PARTS OF THE BODY AS WELL AS THE HIP. PATIENT IS A MALE, 80 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED PRODUCTS, NO PRE-EXISTING ANOMALIES WERE FOUND THUS WE CAN STATE THAT ALL THE COMPONENTS HAD BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    HIP REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2020. ACETABULAR COMPONENTS PREVIOUSLY IMPLANTED ON (B)(6) 2011: DELTA-TT ACETABULAR CUP, PRODUCT CODE 5552.15.600, LOT# 1104520 - STER.1100134. DELTA NEUTRAL LINER ØINT 36MM LARGE SIZE, PRODUCT CODE 5885.51.260, LOT# 1110450 - STER.1100312. BONE SCREW Ø6,5 H.35MM, PRODUCT CODE 8420.15.040, LOT# 1102262 - STER. 1100092 WERE EXPLANTED. ACCORDING TO THE INFO REPORTED, THE DELTA TT ACETABULAR CUP WAS REPLACED WITH A CEMENTED CUP AND THE CEMENT WAS MIXED WITH AN EXTRA DOSE OF ANTIBIOTICS TO COMBAT THE INFECTION. ALSO, THE COMPONENTS ON THE FEMUR: FEM. MODULAR HEAD - L Ø36MM, PRODUCT CODE 5010.09.363, LOT# 1106900 - STER.1100216. REVISION LATER. NECK H.70MM, PRODUCT CODE 7515.15.120, LOT# 1006879 - STER.1000186 WERE EXPLANTED AND REPLACED WITH THE SAME SIZE OPTIONS. SURGEON RESPONSIBLE FOR THE REVISION SURGERY EXPLAINED THAT THE PATIENT INVOLVED HAS MULTIPLE COMORBIDITIES, IS NOT A HEALTHY MAN AND IS IMMUNOSUPPRESSED. THE INFECTION TARGETED OTHER PARTS OF THE BODY AS WELL AS THE HIP. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894385 DELTA-TT ACETAB.CUP 60 MM ACETABULAR CUPS (TI6AL4V) DIA. 60MM FOR LINER SIZE LARGE LPH LIMACORPORATE S.P.A. 5552.15.600 1104520

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention