MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 50; CEMENTLESS ACETABULAR SHELL

Model Number 01.26.50MB

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Osteolysis (2377)

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 28.June.2021: lot 147138: (b)(4) items manufactured and released on 24-jan-2015.Expiration date: 2019-12-31.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 since 2017.Additional implant involved: liner: versafitcup dm 01.26.2850mhc double mobility hc liner ø 50/28 (k092265) lot.136300.Batch review performed on 28.June.2021: lot 136300: (b)(4) items manufactured and released on 3-feb-2014.Expiration date: 2018-12-31.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 since 2017.

Event Description

6 years and 3 months after the primary surgery the patient came in due to developing osteolysis and pain.Liner wear is suspected.The surgeon revised the cup, head, and liner and added a sleeve.

Manufacturer Narrative

Preliminary investigation performed by (b)(4) project manager.From the received information it is not possible to determine the root cause of the event; no photos and parts were received, only general information regarding the liner still assembled with the head.Toggle was noticed between dm liner and femoral head; a certain clearance is present between the two components as design specification: it is not clear if the clearance noticed on the parts was the standard clearance according to the specifications or a wider one due to liner wear.For these reasons we cannot state with certainty the root cause of the event.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 50
• Type of Device: CEMENTLESS ACETABULAR SHELL
• 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: 12179338
• MDR Text Key: 261899254
• Report Number: 3005180920-2021-00587
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030808067
• UDI-Public: 07630030808067
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 01.26.50MB
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 147138
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2015
• 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 Sex: Male