MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 60/28; DOUBLE MOBILITY LINER

Catalog Number	01.26.2860MHC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 24 september 2018.Lot 178299: (b)(4) items manufactured and released on 21 march 2018.Expiration date: 2023-03-06 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.Instrument used reference 01.10.10.004, head impactor, lot unknown.
Event or Problem Description
During head/liner impaction a dimple was generated on the liner.The surgeon swapped the head and liner.The surgery was completed successfully with 5 minutes of delay.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 60/28
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7914098
• Report Number: 3005180920-2018-00724
• Device Sequence Number: 1526479
• Product Code: MEH
• UDI-Device Identifier: 07630030807473
• UDI-Public: 07630030807473
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2023
• Device Catalogue Number: 01.26.2860MHC
• Device Lot Number: 178299
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR