MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X15

Catalog Number	04.01.0154
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 april 2018; lot 163782: (b)(4) items manufactured and released on 15 december 2016.Expiration date: 2021-08-29; 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.Glenoid polyaxial locking screw - l22 reference 04.01.0159 (k170452); lot 165150: (b)(4) items manufactured and released on 15 december 2016.Expiration date: 2021-11-03.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.Glenoid polyaxial locking screw - l18 reference 04.01.0158 (k170452); lot 165149 : (b)(4) items manufactured and released on 15 december 2016.Expiration date: 2021-11-03 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.Std humeral diaphysis - cementless - 12 reference 04.01.0007 (k170452); lot 164509 : (b)(4) items manufactured and released on 20 december 2016.Expiration date: 2021-09-06; 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.Glenosphere 39xø27 reference 04.01.0173 (k170452); lot 163804 : (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.Glenoid polyaxial locking screw - l26 reference 04.01.0160 (k170452); lot 165151: (b)(4) items manufactured and released on 15 december 2016.Expiration date: 2021-11-06.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.Humeral reverse hc liner ø39/+0mm reference 04.01.0122 (k170452); lot 163769: (b)(4) items manufactured and released on 20 december 2016.Expiration date: 2021-09-08; 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.
Event or Problem Description
About 8 months after primary the surgeon revised the patient shoulder for an infection.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X15
• Common Device Name: GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7412279
• Report Number: 3005180920-2018-00221
• Device Sequence Number: 19148518
• Product Code: PHX
• UDI-Device Identifier: 07630040706414
• UDI-Public: 07630040706414
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2021
• Device Catalogue Number: 04.01.0154
• Device Lot Number: 163782
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/10/2018
• 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