MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT HOODED 32/PE HC LINER C; HOODED HC PE LINER

Model Number	01.32.3239HCAT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 09.Sep.2020 lot 185991: (b)(4) items manufactured and released on 27-sep-2018.Expiration date: 2023-09-16.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 item involved in the event, batch review performed on 09 september 2020.Ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.188242.Lot 188242: (b)(4) items manufactured and released on 22-jan-2019.Expiration date: 2024-01-09.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.Stem: masterloc 01.39.206 cementless ti coated lat stem size 6 (k151531) lot.184011.Lot 184011: (b)(4) items manufactured and released on 02-oct-2018.Expiration date: 2023-09-20.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 01.32.148dh acetabular shell ø48 two-holes (k1328799) lot.187891.Lot 187891: (b)(4) items manufactured and released on 20-feb-2019.Expiration date: 2024-02-06.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.
Event or Problem Description
Revision surgery performed after 1 year and 3 months after the previous revision due to signs of infection and the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.The previous revision surgery was performed due to infection as well.The head and liner were replaced.

• Brand Name: LINER: MPACT HOODED 32/PE HC LINER C
• Common Device Name: HOODED HC PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10585023
• Report Number: 3005180920-2020-00646
• Device Sequence Number: 16458107
• Product Code: LPH
• UDI-Device Identifier: 07630030811838
• UDI-Public: 07630030811838
• 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: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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: 09/16/2023
• Device Model Number: 01.32.3239HCAT
• Device Catalogue Number: 01.32.3239HCAT
• Device Lot Number: 185991
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/25/2020
• 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