MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 56/28; DOUBLE MOBILITY ACETABULAR LINER

Model Number	01.26.2856MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 may 2020: lot 1905491: (b)(4) items manufactured and released on 13-sept-2019.Expiration date: 2024-09-01.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 involved: ball heads: mectacer 01.29.230h head biolox option 28 (k131518) lot.1906491.Batch review performed on 28may 2020: lot 1906491: (b)(4) items manufactured and released on 31-oct-2019.Expiration date: 2024-10-14.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 additional implant involved: ball heads: mectacer 01.29.243a sleeve size xl (k131518) lot.1811867.Batch review performed on 28 may 2020: lot 1811867: (b)(4) items manufactured and released on 29-apr-2019.Expiration date: 2024-03-15.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 due to signs of infection and the pathogen is unknown.4 moths after primary surgery the surgeon performed a washout and revised the head, option sleeve and liner.The surgery was completed successfully.The agent stated that another company's stem and cup were also explanted and that an antibiotic spacer was implanted.No new medacta components were implanted during this revision.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 56/28
• Common Device Name: DOUBLE MOBILITY ACETABULAR LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10161719
• Report Number: 3005180920-2020-00341
• Device Sequence Number: 2653897
• Product Code: MEH
• UDI-Device Identifier: 07630030807411
• UDI-Public: 07630030807411
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2020

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: 09/01/2024
• Device Model Number: 01.26.2856MHC
• Device Catalogue Number: 01.26.2856MHC
• Device Lot Number: 1905491
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/17/2020
• 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