MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLE; HIP ACETABULAR CUP

Catalog Number	01.38.052DH
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department: cup revised at about 1 year 5 months after primary tha due to pain and malpositioned cup.According to report the cup is positioned too vertical.From the only image provided, it appears there are some radiolucent lines but neither the radiolucencies nor the cup position are patently cause for revision from the radiographic appearance.Batch review performed on 20 february 2024: lot 2206327: (b)(4) items manufactured and released on 10-may-2022.Expiration date: 2027-04-25.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
Revision surgery due to pain and cup positioned too vertical, at about 1 year 5 months after primary.Cup, liner and head revised successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLE
• Common Device Name: HIP ACETABULAR CUP
• 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: 18817503
• Report Number: 3005180920-2024-00103
• Device Sequence Number: 17223320
• Product Code: LPH
• UDI-Device Identifier: 07630030812590
• UDI-Public: 07630030812590
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 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): 03/01/2024

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: 01.38.052DH
• Device Lot Number: 2206327
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2022
• 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: 70 YR
• Patient Sex: Female
• Patient Race: White