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

Catalog Number	01.12.032
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 5 years 10 months after the primary, stem was found to have radiolucent lines on xray.Revision surgery was performed.The stem had no bone ongrowth and the surgeon was able to remove it by pulling it out by hand.Femoral components successfully revised with competitor's components.
Additional Manufacturer Narrative
Batch review performed on 20 february 2024 lot 174405: (b)(4) items manufactured and released on 15-dec-2017.Expiration date: 2022-11-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: revision of the stem after 5 years 10 months after the primary tha on a young male patient.The patient reported pain and from the radiographic image is visible that the stem was radiographically loose.We have no history of the post-operative evolution and therefore we cannot tell if the stem could never find osteointegration with the bone or if a subsequent deterioration of the interface such as low grade infection may have caused the loosening.There is no reason to suspect a defective stem.Preliminary analysis performed by r&d project manager: looking at the image attached to the complaint it is visible the expianted stem covered by patient blood.It seems that no ha residuals are present on the stem body even if only one image is available and it is not possible to confirm this evidence.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.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 reported complaint.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT 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: 18949222
• Report Number: 3005180920-2024-00105
• Device Sequence Number: 20669727
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• 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: 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): 03/21/2024

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: 11/28/2022
• Device Catalogue Number: 01.12.032
• Device Lot Number: 174405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2017
• 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: 52 YR
• Patient Sex: Male