MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 46/22.2; ACETABULAR HC LINER

Catalog Number	01.26.2246MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2019: lot 171726: (b)(4) items manufactured and released on 26-jul-2017.Expiration date: 2022-07-09.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.Additional implant revised (not marketed in us): cup: versacem 01.27.46cmb double mobility metal back cemented ø 46, lot 177458: (b)(4) items manufactured and released on 18-dec-2017.Expiration date: 2022-12-06.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 ((b)(4)).
Event or Problem Description
Revision surgery performed 1 year after primary due to infection.Cup and liner have been removed, the pathogen is unknown.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 46/22.2
• Common Device Name: ACETABULAR HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8644140
• Report Number: 3005180920-2019-00407
• Device Sequence Number: 2017452
• Product Code: MEH
• UDI-Device Identifier: 07630030806834
• UDI-Public: 07630030806834
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 05/27/2019

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: 07/09/2022
• Device Catalogue Number: 01.26.2246MHC
• Device Lot Number: 171726
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/27/2019
• 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
• Patient Age: 76 YR
• Patient Weight: 68