MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4; CEMENTLESS STEM

Model Number	01.12.024
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During the primary surgery, on (b)(6) 2012, the patient sustained a proximal femoral fracture which required a plate 1-day post-op.Presently on (b)(6) 2022, the patient had a fall causing a periprosthetic fracture of the pelvis which resulted in the loosening of the cup.The surgeon revised successfully the femoral head and cup with a competitor dual mobility cup.The stem was well fixed and was left in situ.
Additional Manufacturer Narrative
Batch review performed on 10 may 2022 lot 113773: (b)(4).Expiration date: 2016-11-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs specialist: revision performed 10 years after tha surgery in a male patient.A pelvis fracture occured due to a traumatic event which resulted in the loosening of the cup.From the radiographic image, the pelvis fracture is visible.Additionally, according to report, during the index surgery a intraoperative proximal femoral fracture occured hence the cerclage (visible in the radiographic image) was inserted.No reason to suspect that this event is due to a faulty device.Additional item involved in the event, batch review performed on 10 may 2022.Cup: versafitcup cc trio 01.26.45.0058 acetabular shell cc trio ø 58 (k103352) lot.113837 lot 113837: (b)(4).Expiration date: 2016-10-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14574005
• Report Number: 3005180920-2022-00413
• Device Sequence Number: 6169147
• Product Code: JDI
• UDI-Device Identifier: 07630030802058
• UDI-Public: 07630030802058
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2022

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: 11/30/2016
• Device Model Number: 01.12.024
• Device Catalogue Number: 01.12.024
• Device Lot Number: 113773
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male