MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 48; ACETABULAR CUP

Model Number	01.26.45.0048
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 october 2020.Lot 1902306: 200 items manufactured and released on 21-jun-2019.Expiration date: 2024-06-10.No anomalies found related to the problem.To date, 190 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director early loosening of the acetabular cup in cementless primary tha on a young woman.The only available image shows the cup already mobilized, so no comment can be offered as to the initial position of the cup.An early loosening can be due to insufficient primary stability achieved at the time of primary operation, perhaps followed by excessive stress during rehabilitation.No sign of a defective implant is discernible from the information available.
Event or Problem Description
Tilting of the acetabular cup noted 3 months after the primary operation by a control x-ray.The surgeon offered the patient another operation to reposition the cup in february, but the patient refused because she had no pain.The pain started 2 months ago and she finally accepted the revision surgery.Cup, liner and head have been successfully revised 1 year after primary surgery.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 48
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10776898
• Report Number: 3005180920-2020-00775
• Device Sequence Number: 3657199
• Product Code: LZO
• UDI-Device Identifier: 07630030807756
• UDI-Public: 07630030807756
• 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: 2019
• Device Explanted Year: 2020
• 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): 11/03/2020

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: 06/10/2024
• Device Model Number: 01.26.45.0048
• Device Catalogue Number: 01.26.45.0048
• Device Lot Number: 1902306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 11/03/2020
• 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: 56 YR
• Patient Weight: 57