MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY ACETABULAR SHELL 60; HIP UNCEMENTED SHELL

Model Number	01.32.160MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 october 2020: lot 1810299: (b)(4) items manufactured and released on 29-apr-2019.Expiration date: 2024-04-15.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 devices involved: batch reviews performed on 02 october 2020: liner: versafitcup dm 01.26.2860mhc double mobility hc liner 28/dml (k092265) lot 160256: (b)(4) items manufactured and released on 10-mar-2016.Expiration date: 2021-02-22.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: amistem p 01.18.405 amistem-p std stem size 5 (k173794) lot 1910416: (b)(4) items manufactured and released on 16-apr-2020.Expiration date: 2025-04-06.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 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot 1909749: (b)(4) items manufactured and released on 03-mar-2020.Expiration date: 2025-02-17.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, 1 month after primary surgery, due to signs of infection and the pathogen is unknown.The surgeon performed a washout and removed all components.The surgery was completed successfully.

• Brand Name: MPACT DOUBLE MOBILITY ACETABULAR SHELL 60
• Common Device Name: HIP UNCEMENTED SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10703209
• Report Number: 3005180920-2020-00729
• Device Sequence Number: 3060904
• Product Code: LPH
• UDI-Device Identifier: 07630030861017
• UDI-Public: 07630030861017
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 10/20/2020

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: 04/15/2024
• Device Model Number: 01.32.160MB
• Device Catalogue Number: 01.32.160MB
• Device Lot Number: 1810299
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/20/2020
• 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