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

Catalog Number	01.26.2246M
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	07/05/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: UHMWPE ACETABULAR LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7731839
• Report Number: 3005180920-2018-00572
• Device Sequence Number: 1588367
• Product Code: MEH
• UDI-Device Identifier: 07630030806827
• UDI-Public: 07630030806827
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 01.26.2246M
• Device Lot Number: 083125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention