BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L22

    MDR report key: 10349979 · Received July 31, 2020

    Report

    Report Number
    3005180920-2020-00485
    Event Type
    Injury
    Date Received
    July 31, 2020
    Date of Event
    July 9, 2020
    Report Date
    July 31, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706469
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 JULY 2020: LOT 174282: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-NOV-2018. EXPIRATION DATE: 2022-11-02. 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. 2 DEVICES OF THIS LOT INVOLVED IN THE COMPLAINT. OTHER DEVICES INVOLVED ON THE EVENT: REVERSE SHOULDER SYSTEM 04.01.0157 GLENOID POLYAXIAL LOCKING SCREW - L14 LOT. 174280 (K170452). BATCH REVIEW PERFORMED ON 21 JULY 2020: LOT 174280: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-NOV-2017. EXPIRATION DATE: 2022-11-01. 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. REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 LOT. 174284 (K170452). BATCH REVIEW PERFORMED ON 21 JULY 2020: LOT 174284: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2017. EXPIRATION DATE: 2022-10-08. 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. REVERSE SHOULDER SYSTEM 04.01.0172 GLENOSPHERE 36X27 LOT. 163802 (K170452). BATCH REVIEW PERFORMED ON 21 JULY 2020: LOT 163802: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2016. EXPIRATION DATE: 2011-11-06. 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. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° LOT. 174648 (K170452). BATCH REVIEW PERFORMED ON 21 JULY 2020: LOT 174648: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2017. EXPIRATION DATE: 2022-11-27. 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. REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER 36/+0MM LOT. 173420 (K170452) BATCH REVIEW PERFORMED ON 21 JULY 2020: LOT 173420: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUL-2017. EXPIRATION DATE: 2022-06-18. 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. REVERSE SHOULDER SYSTEM 04.01.0154 GLENOID BASEPLATE Ø27X15 LOT. 163781 (K170452). BATCH REVIEW PERFORMED ON 21 JULY 2020: LOT 163781: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-DEC-2016. EXPIRATION DATE: 2021-08-21. 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 · 1

    DURING THE FIRST SURGERY (2018) THERE WAS AN INTRA-OP CAUDAL GLENOID FRACTURE DURING THE IMPLANTATION OF AN INVERSE SHOULDER IMPLANT. THE SURGEON REPORTED TO AGENT THAT HE HAS IN SUCH CASES 2 OPTIONS: 1) GO FOR A HEMI PROTHESIS OR 2) GO FOR AN INVERSE PROTHESIS BUT IMPLANT IT TOO CRANIAL AND THEN LATER REVISE THE GLENOID SIDE FOR A ANATOMIC POSITION AFTER FRACTURE HEALING AND IN CASE OF PROBLEM. THE SURGEON HAS CHOSEN OPTION 2 TO GO ON. THIS REVISION OF TODAY WAS THE REVISION OF THE OPTION 2 - A "PLANNED REVISION". THE SURGEON TOLD ME THAT THE REVISION IS NOT IMPLANT RELATED. DIAPHYSIS WAS NOT REMOVED. ALL OTHER COMPONENTS WERE REMOVED AND SENT TO SONIFICATION (WHY NOT AVAILABLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813661 REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L22 GLENOID POLYAXIAL LOCKING SCREW PHX MEDACTA INTERNATIONAL SA 04.01.0159 174282 07630040706469

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention