MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM 01.26.2848MHC DOUBLE MOBILITY HC LINER DIAM 48/28; HIP LINER

Model Number 01.26.2848MHC

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 30 july 2021: lot 145385: (b)(4) items manufactured and released on 03-nov-2014.Expiration date: 2019-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2017.Other devices involved: batch review performed on 30 july 2021: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.(k112115) lot.120443 : (b)(4) items manufactured and released on 07-sep-2012.Expiration date: 2017-07-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2017.

Event Description

The patient came in reporting pain and instability due to a leg length discrepancy.The surgeon revised the head and liner 6 years and 2 months after the primary surgery.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DM 01.26.2848MHC DOUBLE MOBILITY HC LINER DIAM 48/28
• Type of Device: HIP 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: 12377531
• MDR Text Key: 268474712
• Report Number: 3005180920-2021-00679
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807244
• UDI-Public: 07630030807244
• 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,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 01.26.2848MHC
• Device Catalogue Number: 01.26.2848MHC
• Device Lot Number: 145385
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2014
• 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