MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY HC LINER SIZE 48/28 L; DOUBLE MOBILITY LINER FOR HIP

Catalog Number 01.26.2848MHC

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

Visual inspection performed by r&d product manager on 21 december 2017 the components were analyzed: the polyethylene surface was intact and the ceramic ball head too; only a small scratch were noticed in the head, most probably occurred during the revision.From the received parts it is not possible to determine the root cause of the event.Batch review performed on 28 december 2017 lot 166698: (b)(4) items manufactured and released on 17 jan 2017.Expiration date: 2022-01-01 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.Mectacer biolox delta ceramic ball head 12/14 ø 28 size m 0 reference 01.29.202 (k112115) lot.166623: (b)(4) items manufactured and released on 25 jan 2017.Expiration date: 2022-01-10 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 Description

The patient came in due to signs of infection.The surgeon washed out the hip and swapped the head and liner.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY HC LINER SIZE 48/28 L
• Type of Device: DOUBLE MOBILITY LINER FOR HIP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7150719
• MDR Text Key: 95914807
• Report Number: 3005180920-2017-00793
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807244
• UDI-Public: 07630030807244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Catalogue Number: 01.26.2848MHC
• Device Lot Number: 166698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention