MAUDE Adverse Event Report: Medacta International SA Quadra H femoral stems; QUADRA "H" Short neck, cem.less, lat., HAP S.1

Model Number	01.12.31SN
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed due to stem loosening about 1 year and 2 months after the primary surgery.
Additional Manufacturer Narrative
Batch review performed on 13 august 2026 lot 2109716: (b)(6) items manufactured and released on 24-nov-2021.Expiration date: 04-nov-2026.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold with no similar reported event 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.

• Brand Name: Quadra H femoral stems
• Common Device Name: QUADRA "H" Short neck, cem.less, lat., HAP S.1
• 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: 50474969
• Report Number: 3005180920-2026-00876
• Device Sequence Number: 10395931
• Product Code: JDI
• UDI-Device Identifier: 07630030802713
• UDI-Public: 07630030802713
• Combination Product (Y/N): N
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 01.12.31SN
• Device Lot Number: 2109716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2021
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 195 LB
• Patient Race: White