MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY LINER 28/DMD; HIP SHELL DOUBLE MOBILITY LINER

Catalog Number 01.26.2848M

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 11/05/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 27 november 2023: lot 091602: (b)(4) manufactured and released on 01-sep-2009.Expiration date: 2014-jul-31.No anomalies found related to the problem.To date, 34 items of the same lot have been sold with no similar reported event during the period of review.Additional device involved batch review performed on 11 december 2023: cocr 01.25.012 cocr ball head 12/14 28 size m 0 (k072857) lot 091341: (b)(4) manufactured and released on 18-aug-2009.Expiration date: 2014-jun-30.No anomalies found related to the problem.To date, 79 items of the same lot have been sold with no similar reported event during the period of review.

Event Description

The patient came in due to signs of an infection and the pathogen is unknown.About 13 years and 11 months after the primary surgery, the surgeon performed a washout and revised the liner and head.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY LINER 28/DMD
• Type of Device: HIP SHELL DOUBLE MOBILITY LINER
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18301138
• MDR Text Key: 330169210
• Report Number: 3005180920-2023-00999
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807237
• UDI-Public: 07630030807237
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Catalogue Number: 01.26.2848M
• Device Lot Number: 091602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2009
• 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