MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 58/28; HIP SHELL LINER

Model Number	01.26.2858MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07.Feb.2020: lot 187929: (b)(4) items manufactured and released on 29-nov-2018.Expiration date: 2023-11-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar event reported.Additional device involved: batch review performed on 07.Feb.2020: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 28 size m 0 (k112115) lot 187071: (b)(4) items manufactured and released on 6-dec-2018.Expiration date: 2023-11-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar event reported.
Event or Problem Description
Revision surgery needed after 9 months from the primary due to signs of an infection.The pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 58/28
• Common Device Name: HIP SHELL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9755009
• Report Number: 3005180920-2020-00090
• Device Sequence Number: 2216170
• Product Code: MEH
• UDI-Device Identifier: 07630030807442
• UDI-Public: 07630030807442
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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: 11/08/2023
• Device Model Number: 01.26.2858MHC
• Device Catalogue Number: 01.26.2858MHC
• Device Lot Number: 187929
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/26/2020
• 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