MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT PLUS STEM SIZE 10; CEMENTLESS STEM

Model Number	01.39.410
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 march 2021.Lot 180716: (b)(4) items manufactured and released on 19-apr-2018.Expiration date: 2023-04-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional items involved in the event, batch review performed on 3 march 2021: ball heads: mectacer 01.29.213 biolox delta ceramic ball head 12/14 ø 40 size m 0 (k112115) lot.181303.Lot 181303: (b)(4) items manufactured and released on 28-jun-2018.Expiration date: 2023-06-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Liner: mpact 01.32.4052hct flat pe hc liner ø40/g (k122641) lot.177544 lot 177544: (b)(4) items manufactured and released on 17-apr-2018.Expiration date: 2023-03-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Cup: mpact 01.38.060dh acetabular shell ø60 two-hole (k171966) lot.153948 lot 153948: (b)(4) items manufactured and released on 24-feb-2016.Expiration date: 2021-02-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2017.
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 2 years after primary.The surgery was completed successfully.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT PLUS STEM SIZE 10
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11481960
• Report Number: 3005180920-2021-00221
• Device Sequence Number: 3876950
• Product Code: LZO
• UDI-Device Identifier: 07630040715829
• UDI-Public: 07630040715829
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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: 04/10/2024
• Device Model Number: 01.39.410
• Device Catalogue Number: 01.39.410
• Device Lot Number: 180716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/15/2021
• 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
• Patient Age: 63 YR