MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0126 HUMERAL REVERSE HC LINER Ø42/+3MM; SHOULDER REVERSE LINER

Catalog Number 04.01.0126

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

Preliminary investigation performed by production manager joint implants: there was a human positioning error in the fixture of the first-stage semi-finished product because the operator did not follow the procedure that specifies how the part should be positioned.Specifically, the notch of the first stage must match the fixture reference.The operators who performed this step were trained.Human error was possible because the position of the workpiece was not foolproof because it was possible to rotate it 180° on the fixture.Subsequently, the error could not be found because the check on the instruction of control of the final check was not specified.The correct position of the reference gravure on all parts in production until packaging has been checked, finding no nonconforming parts.All newly produced parts will be 100% verified by objectifying the checks.Batch review performed on 09-apr-2024: lot 2342360: 45 items manufactured and released on 28-feb-2024.Expiration date: 2029-02-11.No anomalies found related to the problem.To date, 06 items of the same lot have been sold without any similar reported event.In addition, 21 pieces of the same lot present in medacta warehouses were checked without finding any issues.

Event Description

The line marking for 145/155 degree orientation was placed on the wrong end on the pe liner size 42mm height + 3mm.When inserting the pe liner into the standard reverse metaphysis the surgeon noticed the line marking was on the wrong side.The pe liner was then placed at the correct angle that the surgeon wanted (145 degrees) with the thicker lip of the pe liner placed laterally, despite the line being on the thinner part of the poly.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0126 HUMERAL REVERSE HC LINER Ø42/+3MM
• Type of Device: SHOULDER REVERSE LINER
• 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: 19078445
• MDR Text Key: 340607840
• Report Number: 3005180920-2024-00238
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706339
• UDI-Public: 07630040706339
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.01.0126
• Device Lot Number: 2342360
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2024
• 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): Other
• Patient Age: 75 YR
• Patient Sex: Male