BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0

    MDR report key: 10366571 · Received August 5, 2020

    Report

    Report Number
    3005180920-2020-00517
    Event Type
    Injury
    Date Received
    August 5, 2020
    Date of Event
    July 17, 2020
    Report Date
    August 5, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON (B)(6) 2020: LOT 1906615: 206 ITEMS MANUFACTURED AND RELEASED ON 11-DEC-2019. EXPIRATION DATE: 2024-12-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 189 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT OTHER SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT. REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM LOT. 175042 (K170452) BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON (B)(6) 2020: LOT 175042: 160 ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2017. EXPIRATION DATE: 2022-09-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 156 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE 36XØ24.5 LOT. 179109 (K170452) BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON (B)(6) 2020: LOT 179109: 131 ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2018. EXPIRATION DATE: 2023-03-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 124 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0191 THREADED GLENOID BASEPLATE Ø24.5X30 LOT. 1811893 (K170452) BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON (B)(6) 2020: LOT 1811893: 80 ITEMS MANUFACTURED AND RELEASED ON 18-LUL-2019. EXPIRATION DATE: 2024-07-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 43 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 LOT. 1905799 (K170452) BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON (B)(6) 2020: LOT 1905799: 200 ITEMS MANUFACTURED AND RELEASED ON 13-AUG-2019. EXPIRATION DATE: 2024-07-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 154 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 LOT. 184568 (K170452) BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON (B)(6) 2020: LOT 184568: 306 ITEMS MANUFACTURED AND RELEASED ON 25-APR-2019. EXPIRATION DATE: 2024-04-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 228 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0157 GLENOID POLYAXIAL LOCKING SCREW - L14 LOT. 1905798 (K170452) BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON (B)(6) 2020: LOT 1905798: 30 ITEMS MANUFACTURED AND RELEASED ON 13-AUG-2019. EXPIRATION DATE: 2024-07-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 17 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY 1 MONTH AFTER THE PRIMARY SURGERY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON PLANS TO REVISE THE POLY WITH A THICKER ONE. NO REVISION HAS BEEN SCHEDULED AT THIS TIME. MORE DETAILS TO FOLLOW WHEN THE SURGERY OCCURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833104 REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0 HUMERAL REVERSE METAPHYSIS PHX MEDACTA INTERNATIONAL SA 04.01.0110 1906615 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 Other