MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 3D METAL ACETABULAR SHELL Ø50 TWO-HOLE; CEMENTLES ACETABULAR SHELL

Model Number	01.38.050DH
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At 2 months from primary, revision surgery for acetabular shell loosening.The surgery was completed successfully.All acetabular components and head revised successfully.The patient start to had pain since 1 month after primary.
Additional Manufacturer Narrative
Batch review performed on 06 may 2022: lot 2109312: (b)(4).Expiration date: 2026-08-31.No anomalies found related to the problem.(b)(4).

• Brand Name: CUP: MPACT 3D METAL ACETABULAR SHELL Ø50 TWO-HOLE
• Common Device Name: CEMENTLES ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 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: 14573984
• Report Number: 3005180920-2022-00418
• Device Sequence Number: 20370274
• Product Code: LPH
• UDI-Device Identifier: 07630030812583
• UDI-Public: 07630030812583
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 06/02/2022

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: 08/31/2026
• Device Model Number: 01.38.050DH
• Device Catalogue Number: 01.38.050DH
• Device Lot Number: 2109312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2021
• 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