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

Model Number	01.38.050DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 march 2022.Lot 2006763: (b)(4) items manufactured and released on 07-oct-2020.Expiration date: 2025-09-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional components involved.Liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot.2009602: (b)(4) items manufactured and released on 08-oct-2020.Expiration date: 2025-09-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Stem: masterloc 01.39.206 cementless ti coated lat stem size 6 (k151531) lot.1904515: (b)(4) items manufactured and released on 17-oct-2019.Expiration date: 2024-10-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.2007631: (b)(4) items manufactured and released on 10-nov-2020.Expiration date: 2025-11-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components, and implanted an antibiotic spacer 11 months after primary.The surgery was completed successfully.

• Brand Name: CUP: MPACT 3D METAL ACETABULAR SHELL Ø50 TWO-HOLE
• Common Device Name: HIP ACETABULAR CUP CEMENTLESS
• 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: 14012351
• Report Number: 3005180920-2022-00233
• Device Sequence Number: 5104003
• 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: 2021
• Device Explanted Year: 2022
• 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): 04/05/2022

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: 09/28/2025
• Device Model Number: 01.38.050DH
• Device Catalogue Number: 01.38.050DH
• Device Lot Number: 2006763
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2020
• 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