MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°; SHOULDER REVERSE METAPHYSIS

Model Number 04.01.0110

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 06/05/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2023 lot 2213748: 50 items manufactured and released on 03-nov-2022.Expiration date: 2027-10-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional components involved in the event: reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm (k170452) lot.2217120: : (b)(4) items manufactured and released on 04-oct-2022.Expiration date: 2027-09-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Reverse shoulder system 04.01.0184 short humeral diaphysis - cementless - 11 (k180089) lot.2211938: 5 items manufactured and released on 06-jul-2022.Expiration date: 2027-06-21.No anomalies found related to the problem.To date,(b)(4) items of the same lot have been sold with no similar reported case during the period of review.

Event Description

At about 5 months after the primary, the patient came in reporting pain.It has been reported that the stem was undersized.The surgeon revised successfully the metaphysis, diaphysis, and liner.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°
• Type of Device: SHOULDER REVERSE METAPHYSIS
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17259171
• MDR Text Key: 318576894
• Report Number: 3005180920-2023-00498
• Device Sequence Number: 1
• Product Code: PHX
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/05/2023

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 Model Number: 04.01.0110
• Device Catalogue Number: 04.01.0110
• Device Lot Number: 2213748
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2022
• 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: 72 YR
• Patient Sex: Male