MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT 01.26.2839STT FLAT PE LINER Ø 28 / C; HIP FLAT PE LINER

Model Number	01.26.2839STT
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-jul-2022: lot 101434: (b)(4) items manufactured and released on 08-jun-2010.Expiration date: 2015-04-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.Preliminary investigation performed by r&d manager: looking at the images attached to the complaint the pe liner is visible.It is covered with patient blood, one hole is present on the spherical part done with the screw during revision surgery.Some sings and scratches are present on the liner surface probably due to revision surgery.Additionally one edge of the liner is broken probably due to revision surgery.More information will be added during visual inspection analysis if the part will be available.It is not possible to determine the root cause of reported worn of the inlay.
Event or Problem Description
The patient had a revision surgery due to decentration of the head (standard polyethylene liner).Primary surgery date unknown, lot released in 2010.
Additional Manufacturer Narrative
The liner has been received on sep 30th 2022.Visual inspection performed by r&d project manager.From the analysis of the received piece, an internal eccentricity was noticed.Moreover, some damages were present on the liner due to the removal, both on the rim and on the internal surface.It is not possible to determine the root cause of the event, but this type of event is aligned with literature when standard polyethylene is used in acetabular components.

• Brand Name: LINER: CC E CC LIGHT 01.26.2839STT FLAT PE LINER Ø 28 / C
• Common Device Name: HIP FLAT PE 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: 15121617
• Report Number: 3005180920-2022-00572
• Device Sequence Number: 17576710
• Product Code: LZO
• UDI-Device Identifier: 07630030807107
• UDI-Public: 07630030807107
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: 01.26.2839STT
• Device Catalogue Number: 01.26.2839STT
• Device Lot Number: 101434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2010
• 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: Required Intervention
• Patient Sex: Female