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

Model Number	01.26.45.0048
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 october 2020: lot 146977: (b)(4) items manufactured and released on 28-nov-2014.Expiration date: 2019-10-31.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 since 2016.Additional device involved: batch review performed on 02 october 2020: lot 146040: (b)(4) items manufactured and released on 14-jan-2014.Expiration date: 2019-10-31.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 since 2016.Clinical investigation performed by medacta medical affairs director: 2.5 years after primary cementless tha the cup is revised because it's reported painful.The single image supplied shows a cup not deep enough, and therefore potential source of rubbing against muscles or other tissues.The stems appear to be very small and potentially undersized, but this cannot be fully judged with a single projection.The cause of this revision does not appear to be a defective device.
Event or Problem Description
Revision surgery performed, 2 years and 6 months after primary surgery, due to pain.The surgeon revised successfully the patient shell and liner.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL 48
• Common Device Name: HIP UNCEMENTED SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10746163
• Report Number: 3005180920-2020-00752
• Device Sequence Number: 3180300
• Product Code: LZO
• UDI-Device Identifier: 07630030807756
• UDI-Public: 07630030807756
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: 10/31/2019
• Device Model Number: 01.26.45.0048
• Device Catalogue Number: 01.26.45.0048
• Device Lot Number: 146977
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/28/2020
• 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: 70