MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA P FEMORAL STEMS; QUADRA-P COLLARED STD. SIZE 5

Model Number	01.12.165
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 july 2025.Lot 2401234: (b)(4) items manufactured and released on 16-apr-2024.Expiration date: 2029-04-01.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.Root cause: implant mobilization is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
The patient had hip pain and the surgeon determined the cause was loosening around the lateral shoulder of the implant and the cause is unknown.At about 8 months post primary the surgeon revised the stem, head and liner.The surgery was completed successfully.

• Brand Name: QUADRA P FEMORAL STEMS
• Common Device Name: QUADRA-P COLLARED STD. SIZE 5
• 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: 22803543
• Report Number: 3005180920-2025-00763
• Device Sequence Number: 8950782
• Product Code: LZO
• UDI-Device Identifier: 07630040731898
• UDI-Public: 07630040731898
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K192827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 08/14/2025

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 Model Number: 01.12.165
• Device Lot Number: 2401234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• 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: 74 YR
• Patient Sex: Male
• Patient Race: Black Or African American