MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES

Catalog Number	01.32.156DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 december 2019.Lot 1811191: (b)(4) items manufactured and released on 23-apr-2019.Expiration date: 2024-04-09.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.Other devices involved in the event: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 lot.1900806 (k112115).Batch review performed on 17 december 2019.Lot 1900806: (b)(4) items manufactured and released on 08-may-2019.Expiration date: 2024-04-23.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: impact 01.32.3648hct flat pe hc liner ø36/f lot.184754 (k103721).Batch review performed on 17 december 2019.Lot 184754: (b)(4) items manufactured and released on 04-sep-2018.Expiration date: 2023-08-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 2 other similar reported events.
Event or Problem Description
The patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and removed the cup, head and liner 7 weeks after primary.A new head and liner were cemented in place to act as a temporary spacer.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9580028
• Report Number: 3005180920-2019-01138
• Device Sequence Number: 3080210
• Product Code: LPH
• UDI-Device Identifier: 07630030810855
• UDI-Public: 07630030810855
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2020

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: 04/09/2024
• Device Catalogue Number: 01.32.156DH
• Device Lot Number: 1811191
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/13/2020
• 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