MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA P FEMORAL STEMS; QUADRA-P CEMENTED STD. SIZE1

Model Number	01.12.211
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 may 2026: lot 2431367: (b)(4) items manufactured and released on 03-mar-2025.Expiration date: 2030-feb-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
The patient had primary surgery using competitor products.On (b)(6) 2026, the patient`s competitor stem was revised to a quadra-p cemented std.Size5 and a 32mm biolox delta head m.On (b)(6) 2026, the patient came in presenting pain due to a subsided stem as the result of the cement not adhering to the patient`s bone.The surgeon revised the stem to distal stem d 20mm l 140mm straight and revised the head to a same size head.The surgery as completed successfully.

• Brand Name: QUADRA P FEMORAL STEMS
• Common Device Name: QUADRA-P CEMENTED STD. SIZE1
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25328459
• Report Number: 3005180920-2026-00491
• Device Sequence Number: 18593285
• Product Code: LZO
• UDI-Device Identifier: 07630040732086
• UDI-Public: 07630040732086
• Combination Product (Y/N): N
• PMA/510(K) Number: K192827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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 Model Number: 01.12.211
• Device Lot Number: 2431367
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2025
• 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: 34 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Race: White