MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL CC 54; ACETABULAR CUP

Model Number	01.26.54MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 august 2020: lot 148344: (b)(4) items manufactured and released on 24-mar-2015.Expiration date: 2020-02-28.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 since 2016.Additional implant involved: liner: versafitcup dm 01.26.2854mhc double mobility hc liner ø 54/28 (k092265) lot.146555.Batch review performed on 07 august 2020: lot 146555: (b)(4) items manufactured and released on 26-nov-2014.Expiration date: 2019-10-31.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 since 2016.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components (only liner and cup are medacta's products) and implanted an antibiotic spacer 5 years and 3 months after primary.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL CC 54
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10464399
• Report Number: 3005180920-2020-00554
• Device Sequence Number: 2925376
• Product Code: MEH
• UDI-Device Identifier: 07630030808128
• UDI-Public: 07630030808128
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2020

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: 02/28/2020
• Device Model Number: 01.26.54MB
• Device Catalogue Number: 01.26.54MB
• Device Lot Number: 148344
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2020
• Initial Report FDA Received Date: 08/28/2020
• 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