MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM; SHOULDER HUMERAL LINER

Catalog Number 04.01.0120

Device Problem Unstable (1667)

Patient Problem Joint Disorder (2373)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 20 december 2019: lot 175045: (b)(4) items manufactured and released on 27-sept-2017.Expiration date: 2022-09-07.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.Additional device involved: batch review performed on 20 december 2019: reverse shoulder system 04.01.0169 glenosphere 36xø24.5 (k170452) lot 174730: (b)(4) items manufactured and released on 03-nov-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 without any similar reported event.Clinical evaluation performed by medacta medical affairs director: revision of rsa 1,5 years after primary.The report is less than essential, the only problem quoted is glenoid instability.We did not find any evidence that this may be due to a product malfunction, but the information available is of course not sufficient to carry out a full analysis of the situation that led to re-operation.

Event Description

About 1 year and a half after primary revision surgery for glenoid side instability.The surgeon removed all implant successfully.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM
• Type of Device: SHOULDER HUMERAL 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: 9563572
• MDR Text Key: 174143820
• Report Number: 3005180920-2019-01118
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706278
• UDI-Public: 07630040706278
• 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: 01/08/2020

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: Health Professional
• Device Expiration Date: 09/07/2022
• Device Catalogue Number: 04.01.0120
• Device Lot Number: 175045
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/08/2020
• 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