MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM 01.26.2850M DOUBLE MOBILITY LINER Ø 50/28

Model Number 01.26.2850M

Device Problem Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 16 december 2021.Lot 090898: (b)(4).Expiration date: 2014-04-30.No anomalies found related to the problem.(b)(4).

Event Description

The patient came in for a post-op appointment and the surgeon decided to revise the patient following suspected liner wear.The surgeon revised the competitor's head and medacta poly 12 years and 5 months after primary.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DM 01.26.2850M DOUBLE MOBILITY 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 13078037
• MDR Text Key: 283395121
• Report Number: 3005180920-2021-01022
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807275
• UDI-Public: 07630030807275
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Model Number: 01.26.2850M
• Device Catalogue Number: 01.26.2850M
• Device Lot Number: 090898
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2009
• 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
• Patient Sex: Female