MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM; HUMERAL REVERSE LINER

Catalog Number 04.01.0124

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 11/22/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 28 november 2019.Lot 175050: 52 items manufactured and released on 27-sep-2017.Expiration date: 2022-09-07.No anomalies found related to the problem.To date, 28 items of the same lot have been already sold with another similar reported event.Other device involved in the event: reverse shoulder system 04.01.0173 glenosphere 39xø27 lot.179114 (k170452).Batch review performed on 28 november 2019.Lot 179114: 122 items manufactured and released on 26-mar-2018.Expiration date: 2023-03-08.No anomalies found related to the problem.To date, 66 items of the same lot have been already sold with another similar reported event.

Event Description

The patient came in complaining of pain due to a dislocation of the shoulder.The cause of the dislocation is unknown.The surgeon revised the glenoid baseplate, the humeral metaphysis, glenosphere, and all glenoid screws 2 months after primary surgery.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM
• Type of Device: HUMERAL REVERSE LINER
• 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 9464994
• MDR Text Key: 172450115
• Report Number: 3005180920-2019-01065
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706315
• UDI-Public: 07630040706315
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2022
• Device Catalogue Number: 04.01.0124
• Device Lot Number: 175050
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2017
• 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