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

Model Number	01.32.158MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 february 2020: lot 165910: (b)(4) items manufactured and released on 18-jan-2017.Expiration date: 2022-01-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported events.Additional implant involved: liner: mpact dm 01.26.2858mhc double mobility hc liner 28/dmi (k092265) lot.1905492.Batch review performed on 26 february 2020: lot 1905492: (b)(4) items manufactured and released on 17-sept-2019.Expiration date: 2024-09-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported events.Additional implant involved: stem: sms solid 01.36.068 sms solid stem lat size 8 (k181693) lot.182410.Batch review performed on 26 february 2020: lot 182410: (b)(4) items manufactured and released on 07-ago-2018.Expiration date: 2023-07-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported events.Additional implant involved: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.1905634.Batch review performed on 26 february 2020: lot 1905634: (b)(4) items manufactured and released on 01-ago-2019.Expiration date: 2024-09-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported events.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is (b)(6).20 days after primary surgery the surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58
• Common Device Name: DOUBLE MOBILITY ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9811230
• Report Number: 3005180920-2020-00151
• Device Sequence Number: 2921900
• Product Code: LPH
• UDI-Device Identifier: 07630030861000
• UDI-Public: 07630030861000
• Combination Product (Y/N): N
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/08/2022
• Device Model Number: 01.32.158MB
• Device Catalogue Number: 01.32.158MB
• Device Lot Number: 165910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/10/2020
• 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