MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 54/28; ACETABULAR DOUBLE MOBILITY LINER

Catalog Number	01.26.2854MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 6 november 2019: lot 156463: 77 items manufactured and released on 24-feb-2016.Expiration date: 2021-02-06.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Additional implant involved: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.160544.Batch review performed on 6 november 2019: lot 160544: 85 items manufactured and released on 19-apr-2016.Expiration date: 2021-04-07.No anomalies found related to the problem.To date, 78 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed 3 years and 4 months after the primary due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and insert.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 54/28
• Common Device Name: ACETABULAR DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9334344
• Report Number: 3005180920-2019-00984
• Device Sequence Number: 2243932
• Product Code: MEH
• UDI-Device Identifier: 07630030807381
• UDI-Public: 07630030807381
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 11/18/2019

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: 02/06/2021
• Device Catalogue Number: 01.26.2854MHC
• Device Lot Number: 156463
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/18/2019
• 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