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

Catalog Number 04.01.0174

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Unspecified Infection (1930)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

Additional information: patient was affected by alcoholism.Batch review performed on 27 december 2018 lot 163806: (b)(4) items manufactured and released on 20 december 2016.Expiration date: 2021-11-08 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 humeral reverse hc liner ø42/+3mm reference 04.01.0126 (k170452) lot 173397: (b)(4) items manufactured and released on 12 june 2017.Expiration date: 2022-05-25 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 1 similar reported event.Clinical evaluation performed by medical affairs director on december 20, 2018 reverse shoulder luxation occurred 2 months after implantation in a revision case due to infection and luxation of the primary shoulder replacement.According to the report the patient was affected by alcoholism and reduced compliance to the surgeon's indications was reported.We therefore do not see any indication of a faulty device.

Event Description

Medacta reverse system was implanted on (b)(6) 2018 replacing a competitor prosthesis due to shoulder luxation and infection.Two months after the first revision surgery, during the follow-up visit, the surgeon discovered that the medacta shoulder is luxated.All components, except for the diaphysis, have been removed performing a bony increased offset reversed shoulder arthroplasty with bone graft.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27
• Type of Device: GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8202408
• MDR Text Key: 131594861
• Report Number: 3005180920-2018-01039
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706612
• UDI-Public: 07630040706612
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2021
• Device Catalogue Number: 04.01.0174
• Device Lot Number: 163806
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 76 YR