MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58; ACETABULAR CUP

Catalog Number	01.32.158MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 april 2018.Lot 163242: (b)(4) items manufactured and released on 02 august 2016.Expiration date:2021-07-24.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.Amistem h 01.18.141 (k093944) ha coated lat stem size 1: lot 122932: (b)(4) items manufactured and released on 03 october 2012.Expiration date: 2017-08-31.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.Mectacer 01.29.201 (k112115) biolox delta ceramic ball head 12/14 ø 28 size s -3.5: lot 164973: (b)(4) items manufactured and released on 04 november 2016.Expiration date: 2021-10-25.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.Mpact dm 01.26.2858mhc (k092265) double mobility hc liner 28/dmi lot 152105: (b)(4) items manufactured and released on 05 august 2015.Expiration date: 2020-06-30.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
Revision due to signs of infection.The pathogen will not be available.The surgeon revised all components and implanted a spacer on (b)(6) 2018.The surgery was completed successfully.

• Brand Name: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7463818
• Report Number: 3005180920-2018-00277
• Device Sequence Number: 13850948
• Product Code: LPH
• UDI-Device Identifier: 07630030861000
• UDI-Public: 07630030861000
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

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: 07/24/2021
• Device Catalogue Number: 01.32.158MB
• Device Lot Number: 163242
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/26/2018
• 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: 54 YR