MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 56; ACETABULAR COMPONENT

Model Number	01.26.45.0056
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 july 2020: lot 1905157: (b)(4) items manufactured and released on 09-oct-2019.Expiration date: 2024-09-29.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.Additional item involved in the event, batch review performed on 09 july 2020: stem: amistem c 01.18.102 cemented lat stem size 2 (k103189) lot.1905972a.Lot 1905972a: (b)(4) items manufactured and released on 08-jan-2020.Expiration date: 2024-10-14.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 medical affairs manager: hip revision surgery performed 6 months after primary hybrid total hip arthroplasty in an elderly woman ((b)(6) years old) due to an acetabular fracture.No traumatic event was reported.The fracture probably occurred during acetabular preparation and cup impaction and mainly depend on bone morphology and mechanical properties.In this case, there is no reason to suspect a malfunctioning device.
Event or Problem Description
Revision surgery 6 months post primary surgery for acetabular fracture.During the revision also stem came out, so the surgeon decided to revise all joint components.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 56
• Common Device Name: ACETABULAR COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10288603
• Report Number: 3005180920-2020-00446
• Device Sequence Number: 19066495
• Product Code: LZO
• UDI-Device Identifier: 07630030807794
• UDI-Public: 07630030807794
• 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: 2020
• 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): 07/17/2020

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: 09/29/2024
• Device Model Number: 01.26.45.0056
• Device Catalogue Number: 01.26.45.0056
• Device Lot Number: 1905157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 07/17/2020
• 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: 80 YR
• Patient Weight: 84