BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.132 HA COATED STD STEM SIZE 2

    MDR report key: 14945705 · Received July 7, 2022

    Report

    Report Number
    3005180920-2022-00509
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    June 7, 2022
    Report Date
    July 7, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14-JUN-2022 LOT 104023: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-DEC-2010. EXPIRATION DATE: 2015-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: LATE INFECTION IN CEMENTLESS THA, 10 YEARS AND 4 MONTHS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 14-JUN-2022. CUP: VERSAFITCUP 01.26.54MBT ACETABULAR SHELL CC Ø 54 LOT 103195 (DEVICE NOT DISTRIBUTED IN US): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-DEC-2010. EXPIRATION DATE: 2015-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. LINER: MPACT 01.26.3244HCT FLAT PE HC LINER Ø 32 / E (K103352) LOT 103835: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2010. EXPIRATION DATE: 2015-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. SCREWS 01.26.65.45 CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 45 (K103352) LOT 090194: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUN-2009. EXPIRATION DATE: 2014-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. IMPLANTS FROM CERAMTEC 38.49.7175.665.00 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 LOT. 651836 (DEVICE NOT DISTRIBUTED IN US): THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILISATION. DUE TO THE FACT THAT THE FEMORAL HEAD AT ISSUE WAS NOT PROVIDED, CERAMTEC COULD NOT CARRY OUT ANY FURTHER INVESTIGATIONS.

    Description of Event or Problem · 0

    AT ABOUT 11 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON DID A REVISION DUE TO A POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048233 STEM: AMISTEM H 01.18.132 HA COATED STD STEM SIZE 2 HIP COATED STD STEM LZO MEDACTA INTERNATIONAL SA 01.18.132 104023 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention