MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø60

Model Number	01.32.160MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-mar-2020 lot 185439: (b)(4) items manufactured and released on 22-oct-2018.Expiration date: 14.10.2023.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.Other devices involved in the event ball heads: mectacer 01.29.203 biolox delta ceramic ball head 12/14 28 size l +3.5 lot.1903848 (k112115) batch review performed on 11-mar-2020: lot 1903848: (b)(4) items manufactured and released on 24-jul-2019.Expiration date: 14.07.2024.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Stem: amistem p 01.18.438 amistem-p collared std stem size8 lot.178151 (k173794) batch review performed on 11-mar-2020 lot 178151: (b)(4) items manufactured and released on 10-apr-2018.Expiration date: 27.03.2023.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 dm 01.26.2860mhc double mobility hc liner 28/dml lot.1901460 (k092265) lot 1901460: (b)(4) items manufactured and released on 13-may-2019.Expiration date: 28.04.2024.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
The patient came in due to signs of an infection after almost 1 month from the primary surgery, the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø60
• Common Device Name: DOUBLE MOBILITY ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 9826671
• Report Number: 3005180920-2020-00142
• Device Sequence Number: 2422022
• Product Code: LPH
• UDI-Device Identifier: 07630030861017
• UDI-Public: 07630030861017
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2020

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: No Information
• Device Expiration Date: 10/14/2023
• Device Model Number: 01.32.160MB
• Device Catalogue Number: 01.32.160MB
• Device Lot Number: 185439
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/12/2020
• 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