MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM PE LINER; UHMWPE ACETABULAR LINER

Catalog Number 01.26.2246M

Device Problem Naturally Worn (2988)

Patient Problem Joint Disorder (2373)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 26 july 2018: lot 083125: (b)(4) items manufactured and released on 11 december 2008.Expiration date: 2013-10-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.On 27 july the medical affairs director made the following analysis: 9 years after primary cementless double mobility tha the mobile liner was revised to a new one, possible because of wear.The age and activity level of the patient are not specified.Such a duration is compatible with literature reports for standard pe mobile liners.The osteolytic process does not seem to have compromise fixation of metal components, which, according to report, have not been revised.We tend to categorize this event as regular wear and not as an accident.

Event Description

The patient came in complaining of pain.The surgeon believed that the poly was worn.The surgeon revised the medacta liner and another company's head.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DM PE LINER
• Type of Device: UHMWPE ACETABULAR 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7731839
• MDR Text Key: 115410475
• Report Number: 3005180920-2018-00572
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030806827
• UDI-Public: 07630030806827
• 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: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 01.26.2246M
• Device Lot Number: 083125
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2008
• 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