MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL 46

Model Number	01.26.45.0046
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020.Lot 182552: 140 items manufactured and released on 21-jun-2018.Expiration date: 2023-06-13.No anomalies found related to the problem.To date, 126 items of the same lot have been already sold without any other similar reported event.Clinical evaluation.Two years after primary cementless tha the cup is painful and found to be loose.A cranial cavity is present at the implant-bone interface.The cup was possibly a little too lateral, for unspecified reasons it may not have been possible to place it at the bottom of the acetabular cavity with a complete reaming of the superior column.No reason to think that this revision was caused by a defective implant.
Event or Problem Description
Aseptic cup mobilization.The surgeon revised cup, liner and head 1 year and 11 months after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed on (b)(6) 2020.From the received photos, no particular or evident signs are present in the components, so there are no particular suspects for a failure device.According to what stated in the clinical evaluation, a possible cause can be related to the surgery and positioning of the implant, but there is no certainty on this.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL 46
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10800548
• Report Number: 3005180920-2020-00779
• Device Sequence Number: 19816228
• Product Code: LZO
• UDI-Device Identifier: 07630030807749
• UDI-Public: 07630030807749
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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: 06/13/2023
• Device Model Number: 01.26.45.0046
• Device Catalogue Number: 01.26.45.0046
• Device Lot Number: 182552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/29/2020
• 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: 77 YR