MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO 01.26.45.0046 ACETABULAR SHELL CC TRIO Ø 46; HIP ACETABULAR CUP

Catalog Number	01.26.45.0046
Medical Device Problem Codes	Osseointegration Problem (3003); Unintended Movement (3026)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 february 2024 lot 160097: (b)(4) items manufactured and released on 29-apr-2016.Expiration date: 2021-04-03.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs director: revision of the cup 7 years and 7 months after index surgery due to malposition of the cup and it went through the inner wall of the acetabulum.According to report, the cup became loose and then protruded in the acetabular wall.Post-op images after the index surgery were not provided.Lack of information and history prevents a thorough analysis to be performed.Progressive migration of the cup after almost 8 years is a rather unusual event, however it may be a consequence of aseptic loosening, a phenomenon described in literature, whose causes often remain undetermined.No reason to suspect a faulty device.
Event or Problem Description
At 7 years and 7 months post primary the cup protruded in the acetabular wall leading to cup dissociation from the acetabular bone.The surgeon revised successfully all the acetabular components and the ball head.

• Brand Name: CUP: VERSAFITCUP CC TRIO 01.26.45.0046 ACETABULAR SHELL CC TRIO Ø 46
• Common Device Name: HIP ACETABULAR 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: 18892728
• Report Number: 3005180920-2024-00119
• Device Sequence Number: 7598280
• Product Code: LZO
• UDI-Device Identifier: 07630030807749
• UDI-Public: 07630030807749
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2024

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: 04/03/2021
• Device Catalogue Number: 01.26.45.0046
• Device Lot Number: 160097
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2016
• 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: Unknown