MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 50/28; DOUBLE MOBILITY LINER

Catalog Number 01.26.2850MHC

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 11/11/2017

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2017.Versafitcup double mobility hc liner ø 50/28 lot.162319: (b)(4) items manufactured and released on 25 july 2016 expiration date: 2021-06-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event.Cocr ball head 12/14 ø 28 size m 0 (k072857) lot.170152: (b)(4) items manufactured and released on 18 may 2017.Expiration date: 2022-05-03 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 (corynebacterium).The patient was washed out on (b)(6) 2017.No implants were revised.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 50/28
• Type of Device: DOUBLE MOBILITY LINER
• 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: 7095264
• MDR Text Key: 94131004
• Report Number: 3005180920-2017-00734
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807282
• UDI-Public: 07630030807282
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2021
• Device Catalogue Number: 01.26.2850MHC
• Device Lot Number: 162319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2016
• 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