MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+0MM

Model Number 04.01.0122

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

Patient Problem Joint Disorder (2373)

Event Date 05/17/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 16-jun-2020: lot 1910875: (b)(4) items manufactured and released on 03-mar-2020.Expiration date: 18-feb-2025.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Other device involved in the event: reverse shoulder system 04.01.0173 glenosphere 39x27 lot.1909882 (k170452).Batch review performed on 16-jun-2020: lot 1909882: (b)(4) items manufactured and released on 26-mar-2020.Expiration date: 16-mar-2025.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

Reverse shoulder dislocated 2 days after surgery, due to pistoning of about 1cm.New components: glenosphere 39mm lateralized and +6mm liner 39mm.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+0MM
• Type of Device: HUMERAL REVERSE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874, sz; SZ
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 -CHE ; SZ 6874 CHE
• MDR Report Key: 10157888
• MDR Text Key: 195584541
• Report Number: 3005180920-2020-00333
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706292
• UDI-Public: 07630040706292
• 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: Other
• Type of Report: Initial
• Report Date: 06/16/2020

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: No Information
• Device Model Number: 04.01.0122
• Device Catalogue Number: 04.01.0122
• Device Lot Number: 1910875
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2020
• Initial Date FDA Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2020
• 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