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

Model Number	01.26.2856M
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 january 2020: lot 092876: (b)(4) items manufactured and released on 23-dec-2009.Expiration date: 2014-11-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2016.
Event or Problem Description
The patient had pain.The prosthesis was explanted on (b)(6) 2019 and osteolysis was noticed.Primary details are unknown.
Event or Problem Description
The patient had pain.Liner, head and acetabular shell were explanted on the (b)(6) 2019 and osteolysis was noticed.The primary surgery performed on (b)(6) 2010.
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs department: 10 years after dual-mobility cementless tha some osteolytic regions are visible in the proximal femur.The cup is replaced and the femoral cavities apparently filled with bone chips.It is possible that after ten years, the wear products of the standard-pe dm liner have contributed to causing osteolysis.This is in line with findings reported in literature and should not be considered an anomalous behaviour.Visual inspection performed by medacta r&d département: from the pieces analyzed, no particular signs were noticed; some remained parts of bone were present in the macrostructures of the cup and no particular signs were present in the system cup-liner-head.From the received information, it is possible that a wear of the standard pe caused the osteolysis.
Additional Manufacturer Narrative
Batch review performed on 28 january 2020.Lot 092876: (b)(4) items manufactured and released on 12-jan-2010.Expiration date: 2014-11-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2016.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 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: 9710886
• Report Number: 3005180920-2020-00061
• Device Sequence Number: 3650373
• Product Code: MEH
• UDI-Device Identifier: 07630030807404
• UDI-Public: 07630030807404
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2020

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: 11/30/2014
• Device Model Number: 01.26.2856M
• Device Catalogue Number: 01.26.2856M
• Device Lot Number: 092876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/16/2020; 01/16/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 05/13/2020; 12/23/2020
• 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