MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DOUBLE MOBILITY LINER Ø 50/28

Catalog Number	01.26.2850M
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 24 november 2017: 8 years after primary cementless double mobility tha the surgeon executes a partial revision to restore leg length.Some areas of reduced bone density are visible in the fluoroscopy supplied; according to report, the surgeon thinks they can be due to osteolysis.A standard polyethylene dual mobility liner had been originally implanted and it has now been changed to a highly crosslinked model which has a lower wear rate.The stability of the stem must have been assessed as good intraoperatively.Some wear of a double mobility liner after 8 years is normal; the osteolytic response depends on individual factors.Also, no comparison between stem positions at the beginning and at the end of the postoperative history can be made with the information available, therefore assessment of the subsidence is not possible.
Event or Problem Description
Eight years after primary the patient complained leg length discrepancy.The surgeon detected osteosis due to the length discrepancy.The surgeon swapped successfully the patient head and liner.

• Brand Name: VERSAFITCUP DOUBLE MOBILITY LINER Ø 50/28
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7095378
• Report Number: 3005180920-2017-00732
• Device Sequence Number: 917076
• Product Code: MEH
• UDI-Device Identifier: 07630030807275
• UDI-Public: 07630030807275
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2017

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 Catalogue Number: 01.26.2850M
• 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: 11/09/2017
• Initial Report FDA Received Date: 12/07/2017
• 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: 64 YR