MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 3D METAL ACETABULAR SHELL Ø48 MULTI-HOLE THIN; HIP CEMENTLESS SHELL

Catalog Number	01.38.348MH
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient will be revised for cup loosening on the.Information will be updated when available after revision surgery.
Additional Manufacturer Narrative
Batch review performed on 25-apr-2024: lot 2209237: (b)(4) items manufactured and released on 31-may-2022.Expiration date: 2027-05-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At about 10 months after primary, the patient has been revised because of cup loosening.The surgery has been completed successfully.

• Brand Name: CUP: MPACT 3D METAL ACETABULAR SHELL Ø48 MULTI-HOLE THIN
• Common Device Name: HIP CEMENTLESS SHELL
• 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: 19328671
• Report Number: 3005180920-2024-00315
• Device Sequence Number: 3102348
• Product Code: LPH
• UDI-Device Identifier: 07630971212565
• UDI-Public: 07630971212565
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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,Followup
• Report Date (Section B): 06/14/2024

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 Catalogue Number: 01.38.348MH
• Device Lot Number: 2209237
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2022
• 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: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian