MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL 52 TWO-HOLES; HIP CEMENTLESS SHELL

Model Number	01.32.152DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 june 2021: lot 1907399: 174 items manufactured and released on 04-dec-2019.Expiration date: 2024-11-24.No anomalies found related to the problem.To date, 173 items of the same lot have been already sold with two similar events reported.Additional devices involved liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot 1907433: 154 items manufactured and released on 01-oct-2019.Expiration date: 2024-09-17.No anomalies found related to the problem.To date, 147 items of the same lot have been already sold with two similar reported events.Stem: amistem p 01.18.401 amistem-p std stem size 1 (k173794) lot 1908256: 150 items manufactured and released on 15-gen-20.Expiration date: 2024-12-17.No anomalies found related to the problem.To date, 124 items of the same lot have been already sold without any similar reported event.Ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot 1908993: 300 items manufactured and released on 12-feb-20.Expiration date: 2025-02-01.No anomalies found related to the problem.To date, 295 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
11 months after the primary surgery the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SHELL 52 TWO-HOLES
• Common Device Name: HIP CEMENTLESS SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12038956
• Report Number: 3005180920-2021-00513
• Device Sequence Number: 4094201
• Product Code: LPH
• UDI-Device Identifier: 07630030810794
• UDI-Public: 07630030810794
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 06/22/2021

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: 11/24/2024
• Device Model Number: 01.32.152DH
• Device Catalogue Number: 01.32.152DH
• Device Lot Number: 1907399
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention