MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPRES NECK PRESERVING STEM; HIP STEM

Model Number	01.37.006
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As a result of the pain reported by the patient, an examination was made, which showed a major sinking of the stem, resulting in joint limitation and lameness.The patient requested surgery.Five months after the primary, the patient underwent surgery but, as the stem was well fixed, the surgeon did not remove the stem (also considering the patient's age, 81), and cleaned out ossifications, and replaced the head to reestablish the correct geometry of the joint.
Additional Manufacturer Narrative
Batch review performed on 7 october 2024.Lot: 2213834: (b)(4) items manufactured and released on 13-dec-2022.Expiration date: 2027-nov-30.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 clinical affairs department a few months after the implantation of a primary total hip arthroplasty (tha), the patient experienced pain associated with stem subsidence.Subsequently, the patient reported a leg length discrepancy, leading to functional difficulties and ultimately deciding to undergo revision surgery.During the revision, performed five months after the primary procedure, the surgeon found the stem stable and left it in place, only replacing the femoral head to restore the proper leg length.Available x-ray and ct images show leg shortening, with the lesser trochanter resulting higher than the contralateral side, but no radiolucencies or other signs of loosening are visible.The cause of the subsidence remains unclear.While factors such as bone quality or potential initial undersizing of the implant may have contributed to the issue, we do not have sufficient information to draw definitive conclusions.Although no root definitive root cause could be established, the quality of the patient's bone and the size of the chosen implant may have influenced the reported problem.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.

• Brand Name: MPRES NECK PRESERVING STEM
• Common Device Name: HIP STEM
• 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: 20567799
• Report Number: 3005180920-2024-00874
• Device Sequence Number: 12730779
• Product Code: LZO
• UDI-Device Identifier: 07630345713384
• UDI-Public: 07630345713384
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K210263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/30/2024

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: 01.37.006
• Device Lot Number: 2213834
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2022
• 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: 81 YR
• Patient Sex: Female