MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DOUBLE MOBILITY HC LINER 28/DMF

Model Number	01.26.2852MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 october 2020.Lot 2000168: 165 items manufactured and released on 07-apr-2020.Expiration date: 2025-03-15.No anomalies found related to the problem.To date, 87 items of the same lot have been already sold without any similar reported event.Additional items involved in the event, batch review performed on 08 october 2020.Ball heads: cocr 01.25.012 cocr ball head 12/14 ø 28 size m 0 (k072857) lot.1910796 lot 1910796: 150 items manufactured and released on 16-mar-2020.Expiration date: 2025-03-03.No anomalies found related to the problem.To date, 108 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in, 1 month after primary surgery, due to signs of infection and the pathogen is unknown.The surgeon performed an i&d and revised the head and liner.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DOUBLE MOBILITY HC LINER 28/DMF
• Common Device Name: DOUBLE MOBILITY HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10748130
• Report Number: 3005180920-2020-00747
• Device Sequence Number: 3180305
• Product Code: MEH
• UDI-Device Identifier: 07630030807343
• UDI-Public: 07630030807343
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: 03/15/2025
• Device Model Number: 01.26.2852MHC
• Device Catalogue Number: 01.26.2852MHC
• Device Lot Number: 2000168
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/28/2020
• 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