MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY LINER 28/DMF

Catalog Number	01.26.2852M
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 october 2018.Lot 092227: (b)(4) items manufactured and released on 23 september 2009.Expiration date: 201-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event.Clinical evaluation performed by medical affair manager on october 04, 2018.Femoral head and polyethylene double mobility liner revision occurred 9 years after primary implantation.According to the surgeon, the reason of this event is osteolysis.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.Preliminary investigation performed by r&d product manager on september 18, 2018 preliminary visual investigation on pe liner highlights ceramisis-like area extending from the polar region towards the equator.This suggests that the predominant wear mechanics was burnishing, which is also in line with the clinical outcome and reason for revision.Pe liner color is due to biologic fluids absorption and possible oxidation effects during the long term in-situ time.In-house visual inspection is suggested.
Event or Problem Description
During a routine follow up visit, the surgeon noticed osteolysis on the x-ray 9 years after the primary surgery.The surgeon revised the head and liner.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY LINER 28/DMF
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7938082
• Report Number: 3005180920-2018-00756
• Device Sequence Number: 13902614
• 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: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

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: 09/23/2009
• Device Catalogue Number: 01.26.2852M
• Device Lot Number: 092227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 10/05/2018
• 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: 61 YR