MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DOUBLE MOBILITY LINER Ø 52/28

Catalog Number	01.26.2852M
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	10/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 17 november 2017 the medical affairs performed a clinical evaluation and commented as follows: femoral head and polyethylene double mobility liner revision occurred 7 years after primary total hip arthroplasty.Pre-revision xrays are not supplied.According to the report, the patient was complaining about pain.Osteolysis may be the consequence of polyethylene wear that is commonly seen and described in literature, however wear was not measured in this case and therefore correlation is not established.Batch review performed on 20 november 2017.Lot 092227: (b)(4) items manufactured and released on 25 september 2009.Expiration date: 2014-08-31.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.On 22 november 2017 the r&d project manager performed a preliminary investigation based on the available images and commented as follows: the images show the liner explanted: no particular signs are visible, the head is internal and some blood is present in the external surface and internally.From the images it is not possible to determine the root cause of the event.
Event or Problem Description
The patient came in complaining of pain.The patient presented with early stage osteolysis around the proximal portion of the femur.The surgeon revised the head and liner.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DOUBLE MOBILITY LINER Ø 52/28
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7052727
• Report Number: 3005180920-2017-00686
• Device Sequence Number: 18849302
• Product Code: MEH
• UDI-Device Identifier: 07630030807336
• UDI-Public: 07630030807336
• 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: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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: 08/31/2014
• Device Catalogue Number: 01.26.2852M
• Device Lot Number: 092227
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/22/2017
• 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: 57 YR