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

Catalog Number	01.26.45.0050
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20-jul-2023: lot 2239457: (b)(4) items manufactured and released on 11-jan-2023.Expiration date: 2027-12-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: revision 3 months since the primary tha due to a loose cup.According to report, since the cup was loose, it migrated superiorly.The position of the acetabular cup appears to be inadequate.Since only one post-operative radiographic image is provided we cannot tell if this is the result of post-surgery migration or the surgeon's choice: in the latter case, no explanation for this decision was supplied.
Event or Problem Description
At 3 months from the primary, the patient came in reporting pain due to a loose cup that had migrated superior and the cause is unknown.The surgeon revised the medacta cup and liner with a competitor cup and liner and revised the medacta head with a medacta head.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50
• Common Device Name: CEMENTLESS CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17413459
• Report Number: 3005180920-2023-00613
• Device Sequence Number: 7135401
• Product Code: LZO
• UDI-Device Identifier: 07630030807763
• UDI-Public: 07630030807763
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 07/28/2023

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 Catalogue Number: 01.26.45.0050
• Device Lot Number: 2239457
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2023
• 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: Female