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

Catalog Number 01.26.2850MHC

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Bacterial Infection (1735)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 17 july 2018.Lot 177526: (b)(4) items manufactured and released on 20 february 2018.Expiration date: 2023-02-04.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 28 size m 0 reference (b)(4).Lot 174021: (b)(4) items manufactured and released on 06 december 2017.Expiration date: 2022-11-23.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

About 2 months after primary the surgeon revised the patient hip for a relapse infection.Ceramic head and liner swap.The surgery has been completed successfully.The pathogen is staphylococcus.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY HC LINER DIAM 50/28
• Type of Device: DOUBLE MOBILITY CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7698436
• MDR Text Key: 114319942
• Report Number: 3005180920-2018-00513
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2023
• Device Catalogue Number: 01.26.2850MHC
• Device Lot Number: 177526
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2023
• 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