MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2; HIP CEMENTLESS STEM

Catalog Number	01.12.022
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 7 years 11 months after the primary, revision surgery performed due to aseptic stem loosening (right side).All components were successfully revised.Quadra-h was revised with quadra-r.
Additional Manufacturer Narrative
Batch review performed on 21 june 2024: lot 160081: (b)(4) items manufactured and released on 26-apr-2016.Expiration date: 2021-04-19.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 medacta medical affairs manager: a revision surgery was performed about 8 years after the primary implant of a tha (right side).The patient complained of pain and the reported reason was aseptic loosening of the stem.The available x-rays confirm the loosening of the stem with radiolucency lines on both the medial and lateral sides.Additionally, distal cortical thickening is evident, which, in conjunction with local demineralization of the greater trochanter, indicates a condition of stress shielding.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The exact reason for this failure cannot be determined.Investigation performed by medacta r&d hip project manager: looking at the images attached to the complaint it is visible the explanted stem covered with patient blood.The stem is wrapped in a gauze and only proximal part is visible.Some scratches are present on the neck part probably due to revision surgery.It is not possible to define the root cause of reported complaint.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19749802
• Report Number: 3005180920-2024-00511
• Device Sequence Number: 15086084
• Product Code: JDI
• UDI-Device Identifier: 07630030802034
• UDI-Public: 07630030802034
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• 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): 07/16/2024

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: 04/19/2021
• Device Catalogue Number: 01.12.022
• Device Lot Number: 160081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2016
• 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 Age: 80 YR
• Patient Sex: Male