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

Catalog Number	01.26.2854MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 january 2019.Lot 171730: (b)(4) items manufactured and released on 27 july 2017.Expiration date: 2022-07-14 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.Biolox delta ceramic ball head 12/14 ø 28 size l +3.5 reference 01.29.203 (k112115).Lot 176812: (b)(4) items manufactured and released on 29 march 2018.Expiration date: 2023-03-13.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.
Event or Problem Description
The patient came in, two weeks after primary surgery, due to signs of infection and the pathogen is unknown.The surgeon revised the head and liner and the surgery was completed successfully.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMG
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8260593
• Report Number: 3005180920-2018-01111
• Device Sequence Number: 2081534
• Product Code: MEH
• UDI-Device Identifier: 07630030807381
• UDI-Public: 07630030807381
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

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: 07/14/2022
• Device Catalogue Number: 01.26.2854MHC
• Device Lot Number: 171730
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/18/2019
• 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