MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 8; CEMENTLESS HIP STEM

Model Number	01.12.028
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 november 2020: lot 2002652: (b)(4) items manufactured and released on 24-jul-2020.Expiration date: 2025-07-22.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.
Event or Problem Description
4 days after the primary surgery, the stem slid a little bit deeper into the bone.On x-rays a longitudinal fracture of the femur was discovered.The surgeon explanted the stem and he did 5 cerclages around the femur and implanted a quadra r stem size 6.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 8
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11009860
• Report Number: 3005180920-2020-00894
• Device Sequence Number: 4562865
• Product Code: JDI
• UDI-Device Identifier: 07630030802096
• UDI-Public: 07630030802096
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 12/15/2020

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: 07/22/2025
• Device Model Number: 01.12.028
• Device Catalogue Number: 01.12.028
• Device Lot Number: 2002652
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/15/2020
• 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