MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54; HIP ACETABULAR SHELL

Catalog Number	01.26.45.0054
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30-july-2019.Lot 152646: (b)(4) items manufactured and released on 11-sept-2015.Expiration date: 2020-08-19.To date, all items of the same lot have been already sold without any other similar reported event.Clinical evaluation.Revision of the acetabular component performed 3 years and 3 months after primary cementless total hip arthroplasty in a patient affected by lower limb abnormalities.The choice of cup size and inclination were probably suggested by the patient anatomy that cannot be assessed not having a preoperative x-ray.
Event or Problem Description
The surgeon believed that the primary cup was oversized and too inclined.In fact the patient felt pain and had abnormal anatomy/gait.Cup, liner and ball head were revised 3 years and 4 month and a half after primary.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8919937
• Report Number: 3005180920-2019-00699
• Device Sequence Number: 1904330
• Product Code: LZO
• UDI-Device Identifier: 07630030807787
• UDI-Public: 07630030807787
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2019

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: 08/19/2020
• Device Catalogue Number: 01.26.45.0054
• Device Lot Number: 152646
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/22/2019
• 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: 30 YR