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
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2024-00238
• Device Sequence Number: 6424403
• Product Code: PHX
• UDI-Device Identifier: 07630040706339
• UDI-Public: 07630040706339
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 04.01.0126
• Device Lot Number: 2342360
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male