MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA R FEMORAL STEMS; QUADRA R - STEM CEMENT-LESS HAP 12/14 S. 0

Model Number	01.12.060
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was evaluated on an outpatient basis for left hip pain and cruralgia following multiple revision surgeries of the left total hip arthroplasty.Approximately 7 years and 7 months after the primary, a revision surgery was performed due to stem loosening.The surgeon removed the stem, the head, and two metallic cerclage wire fragments at the femoral site.This was followed by reimplantation of a non-cemented modular conical stem and a ceramic femoral head, as well as fixation of the cortical window using the supercable cerclage system by kinamed.
Additional Manufacturer Narrative
Batch review performed on 19 february 2026.Stem: quadra -r 01.12.060 quadra r - stem cement-less hap 12/14 s.0 (k082792) lot 167945: (b)(4) items manufactured and released on 01-feb-2017.Expiration date: 22-jan-2022.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Root cause: aseptic loosening is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.

• Brand Name: QUADRA R FEMORAL STEMS
• Common Device Name: QUADRA R - STEM CEMENT-LESS HAP 12/14 S. 0
• 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: 24494914
• Report Number: 3005180920-2026-00118
• Device Sequence Number: 14725461
• Product Code: JDI
• UDI-Device Identifier: 07630030802386
• UDI-Public: 07630030802386
• Combination Product (Y/N): N
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 03/03/2026

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 Expiration Date: 01/22/2022
• Device Model Number: 01.12.060
• Device Lot Number: 167945
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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 Sex: Unknown