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

Catalog Number 04.01.0154

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 03/13/2018

Event Type  Injury  

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 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
• Type of Device: GLENOID BASEPLATE
• 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: 7412279
• MDR Text Key: 104877850
• Report Number: 3005180920-2018-00221
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706414
• UDI-Public: 07630040706414
• 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: 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
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2021
• Device Catalogue Number: 04.01.0154
• Device Lot Number: 163782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• 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