MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5; HIP CEMENTLESS STEM

Model Number	01.12.025
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 the patient had a primary hip surgery.After the primary, the patient suffered a trauma resulting in a bone femoral fracture, which was not treated surgically.Presently, on (b)(6) 2023, the patient was revised because of the subsided stem.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 03-feb-2023.Lot 2005138: (b)(4) manufactured and released on 14-aug-2020.Expiration date: 2025-08-05.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of the review.Clinical evaluation performed by medacta medical affairs manager: revision 10 months after primary total hip surgery due to a subsided stem consequent to a femoral fracture.After the primary, the patient suffered a trauma resulting in a femoral fracture, which was not treated surgically.From the radiographic image, the subsided stem is visible.It is probable that due to the (early) trauma the stem subsided.There is no reason to suspect a faulty device.
Additional Manufacturer Narrative
Visual inspection performed by r&d manager: looking at the stem body an opaque white film is visible on approximately whole of the stem length.It is not possible to identify if this film is ha or bone residual, or a combined effect.Absorption of ha from the stem body can indicate that metabolic activity was taking place and that, presumably, adequate bone contact was achieved at the time of surgery.The post-op x-ray analysis could possibly provide more insight, such as the evaluation of possible early rotational instability or initial stress-shielding.Some signs of minor damage and scratches are present on the neck of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue.Based on the analysis completed and information available, it is not possible to identify a root cause of the stem loosening reported, even if the fracture could be a possible cause.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5
• 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: 16435257
• Report Number: 3005180920-2023-00093
• Device Sequence Number: 15285271
• Product Code: JDI
• UDI-Device Identifier: 07630030802065
• UDI-Public: 07630030802065
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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: 08/05/2025
• Device Model Number: 01.12.025
• Device Catalogue Number: 01.12.025
• Device Lot Number: 2005138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2020
• 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