MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK; CEMENTLESS HIP STEM

Catalog Number	01.12.23SN
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager on (b)(6) 2018 periprosthetic femoral fracture occurred few weeks after cementless total hip arthroplasty in an overweight (b)(6) woman.The fracture was probably caused by a little trauma occurred during the postoperative rehabilitation period of time and a subsequent traumatic event caused its displacement: the normal bone weakening due to intraoperative femoral preparation and the patient weight may have also contributed.In this case, there is no reason to suspect a faulty device.Batch review performed on 16 august 2018.Lot 174078: (b)(4) items manufactured and released on 24 october 2017.Expiration date: 2022-10-12.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
Patient presented with thigh pain a few weeks post procedure, returning to hospital post thr where a fracture was noted.After that, 1 month and half after the primary surgery, the patient fell out of bed and displaced the pre-existing fracture.All implants were able to remain in place, with cables & plates to relocate fracture.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7793262
• Report Number: 3005180920-2018-00608
• Device Sequence Number: 1143350
• Product Code: JDI
• UDI-Device Identifier: 07630030802638
• UDI-Public: 07630030802638
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

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: 10/12/2022
• Device Catalogue Number: 01.12.23SN
• Device Lot Number: 174078
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/17/2018
• 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: 57 YR