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

Model Number	01.26.45.0050
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6).2021: lot 152638: 150 items manufactured and released on (b)(6) 2015.Expiration date: 2020-08-19.No anomalies found related to the problem.To date, 148 items of the same lot have been already sold without any similar reported event since (b)(6) 2017.Additional implant involved.Stem.Quadra-h 01.12.23sn cementless, ha coated std stem size 3, short neck (b)(4).Lot.111897 batch review performed on (b)(6) 2021: lot 111897 40 items manufactured and released on (b)(6) 2011.Expiration date: 2016-06-30.No anomalies found related to the problem.To date, 39 the items of the same lot have been already sold without any similar reported event since 1-jan-2017.Clinical evaluation performed by medical affairs director a tha bilateral patient undergoes revision of the right hip, originally implanted in 2016.The cause of revision should be attributed to the extensive spinal fusion procedure intervened after hip replacement.This changed the spino-pelvic relationship and caused discomfort.No reason to think of a defective implant.
Event or Problem Description
The patient returned with pain, in particular a feeling of impingement when flexed seated stem-cup, with a feeling like it may lever out dislocate.The patient had not dislocated though.The surgeon believes the pain reason is due to the extensive spinal fusion, a surgery that was performed by another neurosurgeon post the primary hip replacement causing an extremely stiff lumbar spine.5 years after primary the surgeon revised the acetabular component via an anterior approach, using the mpact cup and dm converter, with a revision sleeve and head.The surgery was technically successful, with adequate leg length and offset achieved.The removed components showed significant edge wear due to femoral stem impingement with the cup, the surgeon believes as a result of the spinal surgery causing changes to the pelvic rotation.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 50
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11421485
• Report Number: 3005180920-2021-00168
• Device Sequence Number: 2776222
• Product Code: LZO
• UDI-Device Identifier: 07630030807763
• UDI-Public: 07630030807763
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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: 08/19/2020
• Device Model Number: 01.26.45.0050
• Device Catalogue Number: 01.26.45.0050
• Device Lot Number: 152638
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 03/05/2021
• 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: 62 YR