BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA PROTRUDED LINER INT 32MM #M

    MDR report key: 11855424 · Received May 20, 2021

    Report

    Report Number
    3008021110-2021-00038
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    May 6, 2021
    Report Date
    October 15, 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 INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE OVERALL NUMBER. THEREFORE, WE CAN ENSURE THAT ALL THE PRODUCTS WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED ONE SINGLE X-RAY REFERRING TO PRE-OP REVISION SURGERY. THE X-RAY RECEIVED - EXACT DATE NOT KNOWN - AND A PICTURE OF EXPLANTED COMPONENTS HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "WHEN THERE WAS A LOT OF PUS FOUND IN THE HIP THE DIAGNOSIS INFECTION IS ABSOLUTELY CLEAR. THE PREVIOUS SURGERY MUST HAVE BEEN QUITE COMPLICATED AND IN SUCH CASES INFECTION IS NOT SO RARE. OF COURSE THIS HAS NOTHING TO DO WITH THE KIND OF IMPLANT CHOSEN". STATING THAT: · CHECK OF STERILIZATION CHARTS OF ALL EXPLANTED COMPONENTS HIGHLIGHTED NO ANOMALIES ON THE PIECES PLACED ON THE MARKET WITH THE SAME LOT #S; · THE MEDICAL EXPERT SUGGESTED THAT "PREVIOUS SURGERY MUST HAVE BEEN QUITE COMPLICATED AND IN SUCH CASES INFECTION IS NOT SO RARE"; IT CAN BE CONCLUDED THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: PMS DATA HAVE BEEN ANALYZED ON THE DELTA REVISION TT CUP AND THE COMPONENT IS NOT SOLD IN THE US. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    REVISION SURGERY OF HIP PROSTHESIS PERFORMED ON (B)(6), 2021, DUE TO INFECTION. IT WAS REPORTED AS WELL THAT COMPONENTS WERE LOOSEN. THE FOLLOWING COMPONENTS WERE EXPLANTED: · DELTA-REVISION-TT ACETABULAR CUP Ø50MM (PRODUCT CODE 5533.38.050, LOT# 1816722 - STER. 1900031) - PRODUCT NOT SOLD IN THE US. · DELTA ANGLED SPACER 20°# L (PRODUCT CODE 5886.15.510, LOT# 1909493 - STER. 1900272) - PRODUCT NOT SOLD IN THE US. · DELTA PROTRUDED LINER ØINT 32MM #M (PRODUCT CODE 5886.51.158, LOT# 1817512 - STER. 1800374). · BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT# 2006424 - STER. 2000214) · BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT# 2000925 - STER. 2000083) · BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT# 2006394 - STER. 2000204) · BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT# 2006398 - STER. 2000209) · BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT# 2006351 - STER. 2000195) ACCORDING TO THE REPORTED INFORMATION, COMPONENTS ON THE FEMUR WERE EXPLANTED AS WELL BUT WERE FROM ANOTHER'S MANUFACTURER. A WASHOUT WAS PERFORMED, AND NEW COMPETITOR'S IMPLANTS WERE PUT IN. IT WAS REPORTED THAT THE GERM RESPONSIBLE FOR THE INFECTION IS NOT KNOWN, HOWEVER IT WAS COMMENTED THAT THERE WAS PUS. PREVIOUS SURGERY TOOK PLACE ON (B)(6), 2020. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF THE PRODUCTS INVOLVED, NO ANOMALIES WERE DETECTED. THUS, WE CAN STATE THAT ALL THE COMPONENTS HAD BEEN PROPERLY 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

    REVISION SURGERY OF HIP PROSTHESIS PERFORMED ON (B)(6) 2021 DUE TO IMPLANT LOOSENING. IT WAS REPORTED THAT PATIENT HAD INFECTION. THE FOLLOWING COMPONENTS WERE EXPLANTED: DELTA-REV.-TT ACET. CUP ¿50MM (PRODUCT CODE 5533.38.050, LOT# 1816722 - STER. (B)(4)) - PRODUCT NOT SOLD IN THE US. DELTA ANGLED SPACER 20¿# L (PRODUCT CODE 5886.15.510, LOT# 1909493 - STER. (B)(4)) - PRODUCT NOT SOLD IN THE US. DELTA PROTR.LINER ¿INT 32MM #M (PRODUCT CODE 5886.51.158, LOT# 1817512 - STER. (B)(4)) BONE SCREW ¿6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT# 2006424 - STER. (B)(4)). BONE SCREW ¿6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT# 2000925 - STER. (B)(4)). BONE SCREW ¿6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT# 2006394 - STER. (B)(4)). BONE SCREW ¿6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT# 2006398 - STER. (B)(4)). BONE SCREW ¿6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT# 2006351 - STER. (B)(4)). ACCORDING TO THE REPORTED INFORMATION, COMPONENTS ON THE FEMUR WERE EXPLANTED AS WELL BUT WERE FROM ANOTHER'S MANUFACTURER. A WASHOUT WAS PERFORMED, AND NEW IMPLANTS WERE PUT IN. IT WAS REPORTED THAT THE GERM RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2020. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750692 DELTA PROTRUDED LINER INT 32MM #M PROTRUDED LINERS (UHMWPE X-LIMA + TI6AL4V) I.D. 32MM - SIZE MEDIUM LPH LIMACORPORATE S.P.A. 5886.51.158 1817512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention