MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1; CEMETLESS HIP STEM

Model Number	01.12.021
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 march 2020: lot 181751: (b)(4) items manufactured and released on 04-jul-2018.Expiration date: 2023-06-19.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 director: 11 months after primary cementless tha the stem is revised.The patient suffered a greater trochanter fracture, which required cerclage, but this most probably caused the stem to subside very significantly and loose press fit and stability.Also, probably due to bone remodelling after fracture healing, the stem finally looks undersized for the "new" femoral shape.The cause of this revision should not be ascribed to a defective implant.Preliminary investigation performed by r&d project manager.Implant covered in bio fluids.
Event or Problem Description
Revision surgery performed, 11 months after primary surgery, due to stem loosening.As per the postoperatory xrays of the primary surgery the patient had a fracture of the greater trochanter of the right femur, for that reason the surgeon used a cerclage with wire.And maybe, this fracture would be a reason of the loosening of the stem.About the revision surgery: intraoperatively, the quadra h stem std size 1 was withdrawn, the stem was totally loosened and without hydroxyapatite, the fracture of the greater trochanter was consolidated, the cerclage was withdrawn, the femoral canal was washed thoroughly, a revision stem of another company was implanted and the medacta femoral head was changed from a cocr 32 xl +7 by a cocr 32 l +3.5.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1
• Common Device Name: CEMETLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9971095
• Report Number: 3005180920-2020-00248
• Device Sequence Number: 16858243
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2020

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: 06/19/2023
• Device Model Number: 01.12.021
• Device Catalogue Number: 01.12.021
• Device Lot Number: 181751
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 04/17/2020
• 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: 40 YR
• Patient Weight: 60