MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES; HIP ACETABULAR SHELL

Catalog Number	01.32.154DH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed due to anterior hip pain at 1 year and 6 months from the primary.The cup, liner and head were removed and replaced with a dual mobility competitor cup.
Additional Manufacturer Narrative
Batch review performed on 08 aug 2024 lot 2204579: (b)(4) items manufactured and released on 22-may-2022.Expiration date: 2027-05-09.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional implants revised batch review performed on 08 aug 2024 on liner: mectacer 01.29.413 ceramic liner ø 36 / e lot.2218800 lot 2218800: (b)(4) items manufactured and released on 27-oct-2022.Expiration date: 2027-10-12.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.Product not marketed in us.Batch review performed on 08 aug 2024 on ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.2211909 lot 2211909: (b)(4) items manufactured and released on 06-sep-2022.Expiration date: 2027-08-23.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.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
• Common Device Name: HIP ACETABULAR 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: 20154723
• Report Number: 3005180920-2024-00684
• Device Sequence Number: 11824184
• Product Code: LPH
• UDI-Device Identifier: 07630030810824
• UDI-Public: 07630030810824
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132879
• 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
• Report Date (Section B): 09/06/2024

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: 01.32.154DH
• Device Lot Number: 2204579
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2022
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White