BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER F. MET.BACK GLEN.SMALL-R

    MDR report key: 17031153 · Received May 31, 2023

    Report

    Report Number
    3008021110-2023-00054
    Event Type
    Injury
    Date Received
    May 31, 2023
    Date of Event
    June 22, 2022
    Report Date
    February 13, 2024
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    KWS
    PMA / PMN Number
    K113254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT # 18AT2N2, NO PRE-EXISTING ANOMALY WAS FOUND. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. THE LINER INVOLVED WAS REQUESTED TO BE RETURNED TO LIMACORPORATE BUT WAS NOT AVAILABLE. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY NO PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE AVAILABLE. BASED ON THE INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT; ·CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #. WE CAN SUPPOSE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF L1 LINERS - BELONGING TO THE FAMILY CODES 1377.50.0XX - DUE TO BREAKAGE IS 0.14%. 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 ISSUES. NOTE - THIS IS FINAL MDR.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT # 18AT2N2, NO PRE-EXISTING ANOMALY WAS FOUND. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 AFTER A PATIENT COMPLAINED FELT PAIN AND "CLICKING/CLUNKING" DURING MOVEMENT. THE SMR ANATOMIC TOTAL PROSTHESIS HAS BEEN REPLACED WITH A SMR REVERSE, DUE TO A DISASSEMBLY OF THE LINER FROM THE METAL BACK (LINER BROKEN). INITIAL SURGERY DATE - (B)(6) 2020, PATIENT - FEMALE, DATE OF BIRTH - (B)(6) 1952, AGE 70 YRS. EXPLANTED COMPONENTS: SMR HUMERAL HEAD Ø48 MM, COMMERCIAL CODE 1322.09.480 - LOT #1912755 - STER. #1900356 NEUTRAL ADAPTOR TAPER STANDARD, COMMERCIAL CODE 1330.15.270 - LOT #1711785 - STER. #1700346 SMR FINNED HUMERAL BODY, COMMERCIAL CODE 1350.15.110 - LOT #1713507 - STER. #1700377 . LINER F. MET.BACK GLEN.SMALL-R COMMERCIAL CODE 1377.50.005 - LOT #18AT2N2 - STER. #1900086.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 AFTER A PATIENT COMPLAINED FELT PAIN AND "CLICKING/CLUNKING" DURING MOVEMENT. THE SMR ANATOMIC TOTAL PROSTHESIS HAS BEEN REPLACED WITH A SMR REVERSE, DUE TO A DISASSEMBLY OF THE LINER FROM THE METAL BACK (LINER BROKEN). INITIAL SURGERY DATE - (B)(6) 2020. PATIENT - FEMALE. DATE OF BIRTH - (B)(6) 1952. AGE 70 YRS. EXPLANTED COMPONENTS SMR HUMERAL HEAD Ø48 MM, COMMERCIAL CODE 1322.09.480 - LOT #1912755 - STER. #1900356. NEUTRAL ADAPTOR TAPER STANDARD, COMMERCIAL CODE 1330.15.270 - LOT #1711785 - STER. #1700346. SMR FINNED HUMERAL BODY, COMMERCIAL CODE 1350.15.110 - LOT #1713507 - STER. #1700377. LINER F. MET.BACK GLEN.SMALL-R COMMERCIAL CODE 1377.50.005 - LOT #18AT2N2 - STER. #1900086.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682721 LINER F. MET.BACK GLEN.SMALL-R LINER F. MET.BACK GLEN.SMALL-R KWS LIMACORPORATE S.P.A 1377.50.005 18AT2N2

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention