MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM, DOUBLE MOBILITY HC LINER SIZE 28/DMD; DOUBLE MOBILITY LINER

Catalog Number 01.26.2848MHC

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 29 march 2016.Lot 136299: (b)(4) items manufactured and released on 13 february 2014.Expiration date: 2018-12-31.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.Cocr ball head 12/14 ø 28 size s -3.5, code 01.25.011, lot.136373 (k072857); (b)(4) items manufactured and released on 18 may 2014.Expiration date: 2019-02-28.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.Not available.

Event Description

Since the primary surgery, the patient felt that one leg was shorter than the other.Clinically the leg length was the same but the surgeon revised the patient's ball head and liner.The surgery was completed successfully.There are no x-rays or explants.

Manufacturer Narrative

On 24 may 2016 it was prepared a final report with the information already submitted in the initial report.On 02 june 2016 the report was sent to the initial reporter and the case was closed.

• Brand Name: VERSAFITCUP DM, DOUBLE MOBILITY HC LINER SIZE 28/DMD
• 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, 6874 ; SZ 6874 ; 91 6966060
• MDR Report Key: 5534507
• MDR Text Key: 41456008
• Report Number: 3005180920-2016-00119
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K092265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 01.26.2848MHC
• Device Lot Number: 136299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/13/2014
• 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
• Patient Age: 65 YR