MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27; METAL GLENOSPHERE

Catalog Number 04.01.0173

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 06/15/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 03 october 2018 lot 174736: (b)(4) items manufactured and released on 26 october 2017.Expiration date: 2022-09-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event ((b)(6)).Additional implant revised: reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm (k170452), lot 175049: (b)(4) items manufactured and released on 27 september 2017.Expiration date: 2022-09-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event ((b)(6)).

Event Description

The patient was revised due to shoulder luxation 2 months after primary.The surgery was successfully performed.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27
• Type of Device: METAL GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7938081
• MDR Text Key: 122816599
• Report Number: 3005180920-2018-00761
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706605
• UDI-Public: 07630040706605
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2022
• Device Catalogue Number: 04.01.0173
• Device Lot Number: 174736
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2017
• 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
• Patient Age: 77 YR