MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID SMS SOLID STEM STD SIZE 12; HIP SOLID STEM

Catalog Number	01.36.052
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 october 2019.Lot 189758: 10 items manufactured and released on 13-feb-2019.Expiration date: 2024-01-31.No anomalies found related to the problem.To date, 2 items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director few days after primary cementless tha a periprosthetic fracture occurred, with consequent subsidence of the femoral stem.No evidence that a defective device caused this adverse event.
Event or Problem Description
Revision due to periprosthethic fracture 9 days after primary.No trauma reported.Stem and head were revised.The surgery was completed successfully.

• Brand Name: STEM: SMS SOLID SMS SOLID STEM STD SIZE 12
• Common Device Name: HIP SOLID STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9238209
• Report Number: 3005180920-2019-00902
• Device Sequence Number: 1934942
• Product Code: LZO
• UDI-Device Identifier: 07630030888717
• UDI-Public: 07630030888717
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 01.36.052
• Device Lot Number: 189758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/25/2019
• 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: 73 YR