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

Model Number 01.26.2856M

Device Problem Material Integrity Problem (2978)

Patient Problem Osteolysis (2377)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 07-jan-2021: lot 100373: (b)(4) items manufactured and released on 23-mar-2010.Expiration date: 28-feb-2015.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.Clinical evaluation performed by medacta medical affairs department: the patient got a primary tha in 2010, and few weeks later he was operated again, probably to correct some biomechanical parameters, if not because of a trochanteric fracture.The greater trochanter was then repositioned with sinthesis devices in early 2011.The stem remained slightly undersized and in varus position.A lateralized stem with a very long head was used, probably to achieve proper tissue tensioning.After 9 years, this delicate construct becomes loose, also because of osteolytic damage to the remains of the proximal femur.Pe wear may have contributed to the degeneration of the proximal femur.A standard pe, double mobility liner was used, probably to counter dislocation risks made higher by the lack of joint tension.Given the situation, we do not recognize signs of abnormal behaviour of the implanted components.Visual inspection performed by medacta r&d department: from the received components it is possible to note that the shell was well osseointegrated, visible for the presence of bone tissue in the macrostructures.The dm liner and head were still assembled together; the external surface of the liner was signed to the presence of several third bodies.From the received information, there are no reasons to suspect a failure of the device, as the wear of standard pe liner commonly occurs in literature; in this case the wear is probably caused by both the normal activity and the presence of third bodies, but it is not possible to determine it with certainty.Another device involved: batch review performed on 07-jan-2021: cup: versafitcup 01.26.56mb acetabular shell ø 56 (k083116)lot.100748.Lot 100748: (b)(4) items manufactured and released on 08-jun-2010.Expiration date: 30-apr-2015.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.

Event Description

Revision surgery performed due to osteolysis at the level of the cup and decentralization of the head (9 years and 2 months after the primary surgery).The polyethylene wear is suspected.

• Brand Name: LINER: VERSAFITCUP DOUBLE MOBILITY LINER 56/28
• Type of Device: LINER: 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 11138876
• MDR Text Key: 225732697
• Report Number: 3005180920-2021-00016
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807404
• UDI-Public: 07630030807404
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K083116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 01.26.2856M
• Device Catalogue Number: 01.26.2856M
• Device Lot Number: 100373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2010
• 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: 72 YR