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

Model Number	01.26.45.0050
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 july 2020: lot 165691: (b)(4) items manufactured and released on 22-dec-2016.Expiration date: 2021-12-12.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.Clinical evaluation performed by medacta medical affairs director: hip revision surgery after cementless tha in a (b)(6) year old woman due to psoas impingement with the cup edge.Radiographic image provided shows suboptimal cup position.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.The cause of this revision is not to be sought in a defective device.
Event or Problem Description
Impingement of the psoas.The cup was not well-positioned.3 years and 1 month after primary, revision surgery successfully performed.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 50
• Common Device Name: HIP UNCEMENTED SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10306842
• Report Number: 3005180920-2020-00430
• Device Sequence Number: 860578
• Product Code: LZO
• UDI-Device Identifier: 07630030807763
• UDI-Public: 07630030807763
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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: 12/12/2021
• Device Model Number: 01.26.45.0050
• Device Catalogue Number: 01.26.45.0050
• Device Lot Number: 165691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/22/2020
• 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: 52 YR
• Patient Weight: 49