MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1

Model Number	01.12.031
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 december 2024 (b)(4) items manufactured and released on 18-dec-2019.Expiration date: 2024-12-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medacta clinical affairs manager: a revision surgery was performed approximately two years after the implantation of a primary total hip arthroplasty due to stem mobilization.It was reported that the patient did not comply with the post-operative medical instructions.Post-operative x-ray imaging shows the prosthesis to be well-positioned in this projection, although the stem appears slightly undersized.Pre-revision imaging reveals radiolucent lines around the proximal stem, along with a slight tilt of the stem.Early aseptic loosening is a well-documented complication following tha, often resulting from multifactorial causes.In this case, the slight undersizing of the stem and the patient's premature mobilization against the surgeon's advice may have contributed to the failure.There is no evidence to suggest a defect in the device.Root cause: there is no indication that any potential issue with the device may have caused or contributed to the event, and the investigation does not indicate any potential manufacturing related issue.
Event or Problem Description
Revision surgery for stem mobilization at about 2 years and 10 months post-primary.The surgeon attributes early loosening to the patient being non-compliant with post-operative instructions and mobilizing independently too soon.

• Brand Name: QUADRA H FEMORAL STEMS
• Common Device Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1
• 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: 21100363
• Report Number: 3005180920-2024-01103
• Device Sequence Number: 9154912
• Product Code: JDI
• UDI-Device Identifier: 07630030802133
• UDI-Public: 07630030802133
• 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: 2022
• 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): 01/07/2025

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: 12/08/2024
• Device Model Number: 01.12.031
• Device Lot Number: 146386B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2019
• 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: 71 YR
• Patient Sex: Male