MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 58/28; LINER DOUBLE MOBILITY

Catalog Number	01.26.2858M
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	04/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 04 may 2018; 9 years after primary cementless double-mobility tha the hip became painful, probably because of osteolytic reaction which may have been caused by polyethylene debris.We cannot determine this chain of events from the documentation supplied, but this is possible and, after 9 years of active life of a non-crosslinked pe mobile insert, compatible with current literature.Both stem and cup were not loose.Batch review performed on 07 may 2018; lot 083130: (b)(4) items manufactured and released on 11 december 2008.Expiration date: 2013-10-31.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.Other device involved: versafitcup acetabular shell ø 58 01.26.58mb (k083116); lot 090081: (b)(4) items manufactured and released on 31 march 2009.Expiration date: 2014-02-28; 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.Preliminary investigation performed by r&d product manager on 09 may 2018 from the image of the implants no conclusion can be drawn.
Event or Problem Description
About 9 years after primary the surgeon revised the patient for osteolysis due to poly wear.The surgeon revised the cup, the liner and the ball head.The stem was well fixed.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 58/28
• Common Device Name: LINER DOUBLE MOBILITY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7498737
• Report Number: 3005180920-2018-00315
• Device Sequence Number: 1314732
• Product Code: MEH
• UDI-Device Identifier: 07630030807435
• UDI-Public: 07630030807435
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2018

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: 01.26.2858M
• Device Lot Number: 083130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/09/2018
• 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
• Patient Age: 70 YR