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

Model Number	01.26.50MB
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	06/25/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2021-00587
• Device Sequence Number: 11136218
• Product Code: MEH
• UDI-Device Identifier: 07630030808067
• UDI-Public: 07630030808067
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2021

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male