MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 11; CEMENTLESS HUMERAL DIAPHYSIS

Catalog Number 04.01.0006

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/18/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 20 december 2018: lot 176939: (b)(4) items manufactured and released on 27-feb-2018.Expiration date: 2023-02-14.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 components explanted: reverse shoulder system 04.01.0110, humeral reverse metaphysis +0mm/0°, lot 174650: (b)(4) items manufactured and released on 05-february-2018.Expiration date: 2023-01-25.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.Reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm, lot 179981: (b)(4) items manufactured and released on 24-april-2018.Expiration date: 2023-04-08.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.Due to an human error, the complaint has been reported 1 day in delay to fda (dec 20, 2018 instead of dec 19, 2018).

Event Description

Revision surgery due to infection 3 weeks after the primary surgery.The surgeon revised the metaphysis, humeral stem and inlay.

• Brand Name: REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 11
• Type of Device: CEMENTLESS HUMERAL DIAPHYSIS
• 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: 8184351
• MDR Text Key: 131006466
• Report Number: 3005180920-2018-01027
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706056
• UDI-Public: 07630040706056
• 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: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2023
• Device Catalogue Number: 04.01.0006
• Device Lot Number: 176939
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2018
• 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