MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DOUBLE MOBILITY LINER Ø 56/28

Catalog Number	01.26.2856M
Health Effect - Clinical Codes	Discomfort (2330); Osteolysis (2377)
Date of Event	10/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 10 november 2017 the medical affairs performed a clinical evaluation and commented as follows: total hip revision surgery occurred 8 years after primary double mobility system implantation.Radiographic image provided shows the presence of reduced bone density and osteolytic areas in the acetabular and proximal femur portion.These may be related to the presence of polyethylene debris gathered in thiose areas.No information was provided on patient age, activity level, weight.Batch review performed on 20 november 2017.Lot 083129: (b)(4) items manufactured and released on 09 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.
Event or Problem Description
The patient came in complaining of discomfort.The patient presented with osteolysis around the pelvis, greater trochanter and the femur.The surgeon revised the cup, liner, stem and head.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DOUBLE MOBILITY LINER Ø 56/28
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7057078
• Report Number: 3005180920-2017-00692
• Device Sequence Number: 781340
• Product Code: MEH
• UDI-Device Identifier: 07630030807404
• UDI-Public: 07630030807404
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2017

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 Expiration Date: 10/31/2013
• Device Catalogue Number: 01.26.2856M
• Device Lot Number: 083129
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/23/2017
• 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