MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 60/28; HIP ACETABULAR LINER DOUBLE MOBILITY

Model Number 01.26.2860MHC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 01/19/2022

Event Type  Injury  

Event Description

The patient came in due to signs of an infection and the pathogen is unknown.At 2 months from the primary surgery the surgeon performed a washout and revised the head and liner.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 25 january 2022: lot 2104158: (b)(4) items manufactured and released on 09-jun-2021.Expiration date: 2026-may-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional component involved: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.2103137.Lot 2103137: (b)(4) items manufactured and released on 28-jun-2021.Expiration date: 2026-jun-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 60/28
• Type of Device: HIP ACETABULAR LINER DOUBLE MOBILITY
• 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: 13523956
• MDR Text Key: 285809192
• Report Number: 3005180920-2022-00114
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807473
• UDI-Public: 07630030807473
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/14/2022

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 Model Number: 01.26.2860MHC
• Device Catalogue Number: 01.26.2860MHC
• Device Lot Number: 2104158
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/09/2021
• 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