MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27

Catalog Number 04.01.0174

Device Problem Device Slipped (1584)

Patient Problem Toxicity (2333)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

Additional information received on 27 february 2018 by sales representative that attend the revision surgery: no issue related to the implants.The glenoid components were positioned "too" cranially and consequently the glenosphere did not follow / cover the lower profile of the scapula and this could cause a "mechanical" luxation of the inverse (bone contact / inverse metaphysis-liner).Because of the dislocation and rubbing of the glenosphere with the most proximal part of the inverse metaphysis the patient has developed a "principle of metallosis".Clinical evaluation performed by medical affairs on 09 march 2018: recurrent dislocation of reverse shoulder arthroplasty.This event should be ascribed to a soft tissue deficiency.The surgeon decided to replace liner and glenosphere 4 months after implantation to reestablish soft tissue tension.The implanted components did not mobilize nor did they fail in any way.This problem was not originated by a faulty device.Preliminary investigation performed by r&d product manager on 14 march 2018 the luxation may be caused by low tension of the muscular structures.This hypothesis appears to be confirmed by the change of the liner from +0mm to +6mm.The metallosis seems to be provoked by the contact between the glenosphere and the reverse metaphysis, after implants luxation batch review performed on 21 march 2018; reverse shoulder system glenosphere 42x27 reference 04.01.0174; lot 163805: (b)(4) items manufactured and released on 20 december 2016.Expiration date: 2021-09-21.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.Reverse shoulder system humeral reverse hc liner ø42/+0mm reference 04.01.0125 (k1704529); lot 173412: (b)(4) items manufactured and released on 21 june 2017.Expiration date: 2022-05-31 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.

Event Description

Revision surgery performed due to anterior luxation after 5 months from the primary.Notching between the glenosphere and the metaphysis proximal part caused metallosis.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27
• Type of Device: GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7365115
• MDR Text Key: 103283587
• Report Number: 3005180920-2018-00176
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706612
• UDI-Public: 07630040706612
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2021
• Device Catalogue Number: 04.01.0174
• Device Lot Number: 163805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention