BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL MODULAR HEAD

    MDR report key: 18607377 · Received January 30, 2024

    Report

    Report Number
    3008021110-2024-00012
    Event Type
    Injury
    Date Received
    January 30, 2024
    Date of Event
    October 5, 2023
    Report Date
    September 19, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K141327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE LOT NUMBERS INVOLVED NO PRE-EXISTING ANOMALIES WERE FOUND ON THE COMPONENTS MANUFACTURED WITH THESE LOT NUMBERS. A FINAL REPORT WILL BE SENT AFTER THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    CHECKING THE DHRS CHARTS OF THE LOT NUMBERS INVOLVED NO PRE-EXISTING ANOMALIES WERE FOUND ON THE COMPONENTS MANUFACTURED WITH THESE LOT NUMBERS; THEREFORE, ALL PIECES HAVE BEEN PRODUCED ACCORDING TO SPECIFICATIONS. CHECKING THE STERILIZATION CHARTS, WE CAN STATE THAT ALL PIECES OF THE INVOLVED LOT NUMBERS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. ACCORDING TO OUR DATA AT LEAST (B)(4) PIECES MANUFACTURED WITH LOT. NR. 2111828 - STER. (B)(4) HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED. ACCORDING TO OUR DATA AT LEAST (B)(4) PIECES MANUFACTURED WITH LOT. NR. 2082604 - STER. (B)(4) HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED. ACCORDING TO OUR DATA AT LEAST (B)(4) PIECES MANUFACTURED WITH LOT. NR. 2110901 - STER. (B)(4) HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED. ACCORDING TO OUR DATA AT LEAST (B)(4) PIECES MANUFACTURED WITH LOT. NR. 1907301 - STER. (B)(4) HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED. ACCORDING TO OUR DATA AT LEAST (B)(4) PIECES MANUFACTURED WITH LOT. NR. 2019628 - STER. (B)(4) HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED. EVEN THOUGH REQUESTED TO COMPLAINT SOURCE, THE EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. COMPLAINT SOURCE PROVIDED POST-OP X-RAYS FROM PRIMARY SURGERY AND PHOTO OF EXPLANTS, WHICH WERE SENT TO A MEDICAL CONSULTANT FOR EVALUATION AND HEREBY HIS COMMENT: "WHEN YOU SAY THE HIP WAS SEPTIC THIS ALONE SHOULD BE REASON ENOUGH FOR A REVISION. LOOKING AT THE X-RAY (B)(6) 2022 THE CUP HAS BEEN IMPLANTED NON-ANATOMICALLY AT A HIGH-HIP-CENTRE. SUCH PLACEMENT IS AT RISK OF EARLY LOOSENING OF THE CUP BUT ALSO OF DISLOCATION OF THE INLAY. THE PHOTO OF THE EXPLANTS SHOWS METAL ABRASION AT THE CERAMIC HEAD. THAT MEANS THAT THERE MUST HAVE BEEN SOME METAL CONTACT FOR SOME TIME. THE PE INLAY ON THE EXPLANT PHOTO IS NOT COMPLETELY FIXED IN THE METAL CUP. COULD IT BE THAT THE INLAY HAS DISLOCATED IN SITU BEFORE REVISION AND SUCH THE HEAD WAS IN CONTACT WITH THE CUP? WOULD EXPLAIN THE FINDINGS BUT CAN ONLY BE CONFIRMED WITH AN X-RAY SHORTLY BEFORE (B)(6)." WE CONFIRMED THE ABSENCE OF PRE-EXISTING ANOMALIES BY DHRS CHECK, MOREOVER THE MEDICAL EXPERT, UPON X-RAYS ANALYSIS, COMMENTED: " LOOKING AT THE X-RAY (B)(6) 2022 THE CUP HAS BEEN IMPLANTED NON-ANATOMICALLY AT A HIGH-HIP-CENTRE. SUCH PLACEMENT IS AT RISK OF EARLY LOOSENING OF THE CUP BUT ALSO OF DISLOCATION OF THE INLAY", THEREFORE WE CLASSIFY THE EVENT AS NOT PRODUCT RELATED WITH POSSIBLE CONTRIBUTORY FOR LOOSENING TO SURGICAL FACTORS. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF FEM. MODULAR HEAD- BELONGING TO THE FAMILY CODES (B)(4)- DUE TO INFECTION IS ABOUT (B)(4). ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF FEM. MODULAR HEAD- BELONGING TO THE FAMILY CODES (B)(4) - DUE TO LOOSENING IS ABOUT (B)(4). 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. THIS IS A FINAL MDR REPORT.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO SEPTIC LOOSENING. DEVICES EXPLANTED DURING THE REVISION: H-MAX S STANDARD FEM. STEM #11 (PRODUCT CODE: 4250.20.110, LOT. NR.: 2111828 - STER. 2100227) - SOLD IN US FEM. MODULAR HEAD - L Ø32MM (PRODUCT CODE: 5010.42.323, LOT. NR. 2082604 - STER. 2100097) - SOLD IN US DELTA-PF ACETAB.CUP Ø52 MM (PRODUCT CODE: 5551.25.521, LOT. NR. 2110901 - STER. 2100201) - NOT SOLD IN US DELTA PROTR.LINER ØINT 32MM #L (PRODUCT CODE: 5886.54.160, LOT. NR. 1907301 - STER. 1900278) - NOT SOLD IN US BONE SCREW Ø6,5 H.35MM (PRODUCT CODE: 8420.15.040, LOT. NR. 2019628 - STER. 2000382) - SOLD IN US PATIENT MALE, 52 YEARS OLD. IT WAS REPORTED THAT THE PATIENT HAS AN APPROXIMATE HEIGHT: 183(CM), APPROXIMATE WEIGHT AT THE TIME OF PREVIOUS SURGERY 92(KG) AND APPROXIMATE WEIGHT AT THE TIME OF REVISION SURGERY: 95(KG) EVENT OCCURRED IN EGYPT.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO SEPTIC LOOSENING. PREVIOUS SURGERY DATE IS UNKNOWN (PROBABLY BEGINNING OF YEAR 2022). DEVICES EXPLAHIP REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO SEPTIC LOOSENING. PREVIOUS SURGERY DATE IS UNKNOWN (PROBABLY BEGINNING OF YEAR 2022). DEVICES EXPLANTED DURING THE REVISION: H-MAX S STANDARD FEM. STEM #(B)(4) (PRODUCT CODE: 4250.20.110, LOT. NR.: 2111828 - STER. (B)(4)) - SOLD IN US. FEM. MODULAR HEAD - L Ø32MM (PRODUCT CODE: 5010.42.323, LOT. NR. 2082604 - STER. (B)(4)) - SOLD IN US. DELTA-PF ACETAB.CUP Ø52 MM (PRODUCT CODE: 5551.25.521, LOT. NR. 2110901 - STER. (B)(4)) - NOT SOLD IN US. DELTA PROTR.LINER ØINT 32MM #L (PRODUCT CODE: 5886.54.160, LOT. NR. 1907301 - STER. (B)(4)) - NOT SOLD IN US. BONE SCREW Ø6,5 H.35MM (PRODUCT CODE: 8420.15.040, LOT. NR. 2019628 - STER.(B)(4)) - SOLD IN US PATIENT MALE, 52 YEARS OLD. IT WAS REPORTED THAT THE PATIENT HAS AN APPROXIMATE HEIGHT: 183(CM), APPROXIMATE WEIGHT AT THE TIME OF PREVIOUS SURGERY 92(KG) AND APPROXIMATE WEIGHT AT THE TIME OF REVISION SURGERY: 95(KG) EVENT OCCURRED IN EGYPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2550882 FEMORAL MODULAR HEAD BIOLOX DELTA HEAD 32MM #L, LZO LIMACORPORATE S.P.A. 5010.42.323 2082604

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention