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

Catalog Number 01.26.2850M

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Joint Disorder (2373)

Event Date 11/09/2017

Event Type  Injury  

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 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
• 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
• MDR Report Key: 7095378
• MDR Text Key: 94113159
• Report Number: 3005180920-2017-00732
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807275
• UDI-Public: 07630030807275
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.26.2850M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 64 YR