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

Catalog Number	04.01.0174
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/30/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8202408
• Report Number: 3005180920-2018-01039
• Device Sequence Number: 1631411
• Product Code: PHX
• UDI-Device Identifier: 07630040706612
• UDI-Public: 07630040706612
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2021
• Device Catalogue Number: 04.01.0174
• Device Lot Number: 163806
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR