BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT 01.32.156MH ACETABULAR SHELL Ø56 MULTI-HOLE

    MDR report key: 13567346 · Received February 21, 2022

    Report

    Report Number
    3005180920-2022-00134
    Event Type
    Injury
    Date Received
    February 21, 2022
    Date of Event
    January 25, 2022
    Report Date
    February 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810862
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 JANUARY 2022: LOT 2004892: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2020. EXPIRATION DATE: 2025-10-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 27 JANUARY 2022. LINER: MPACT 01.32.3248HCAT HOODED PE HC LINER Ø32/F (K132879) LOT 1904363: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUNE-2019. EXPIRATION DATE: 2024-06-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BALL HEADS: COCR 01.25.022 COCR BALL HEAD 12/14 Ø 32 SIZE M 0 (K072857) LOT 2006284: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2020. EXPIRATION DATE: 2025-09-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. STEM: MASTERLOC 01.39.210 CEMENTLESS TI COATED LAT STEM # 10 (K151531) LOT 166787B: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-APR-2020. EXPIRATION DATE: 2025-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. SCREWS: MPACT 01.32.6525 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25 (K103721) LOT 2002401: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2020. EXPIRATION DATE: 2025-05-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. SCREWS: MPACT 01.32.6520 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 20 (K103721) LOT 2008456: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-OCT-2020. EXPIRATION DATE: 2025-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 JANUARY 2022: LOT 2004892: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2020. EXPIRATION DATE: 2025-10-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 27 JANUARY 2022. LINER: MPACT 01.32.3248HCAT HOODED PE HC LINER Ø32/F (K132879) LOT 1904363: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUNE-2019. EXPIRATION DATE: 2024-06-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BALL HEADS: COCR 01.25.022 COCR BALL HEAD 12/14 Ø 32 SIZE M 0 (K072857) LOT 2006284: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2020. EXPIRATION DATE: 2025-09-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. STEM: MASTERLOC 01.39.210 CEMENTLESS TI COATED LAT STEM # 10 (K151531) LOT 166787B: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-APR-2020. EXPIRATION DATE: 2025-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. SCREWS: MPACT 01.32.6525 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25 (K103721) LOT 2002401: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2020. EXPIRATION DATE: 2025-05-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. SCREWS: MPACT 01.32.6520 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 20 (K103721) LOT 2008456: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-OCT-2020. EXPIRATION DATE: 2025-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2401227 CUP: MPACT 01.32.156MH ACETABULAR SHELL Ø56 MULTI-HOLE ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.156MH 2004892 07630030810862

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention