MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPRES NECK PRESERVING STEM; MPRES STEM LAT SIZE 9

Model Number	01.37.029
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 jan 2025, lot 2213852: (b)(4) items manufactured and released on 13-dec-2022.Expiration date: 2027-11-30.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 medical affair director.A revision surgery was performed 3 months after the primary implantation of a tha.The reported reason was stem loosening and a periprosthetic fracture resulted from the loosening.The available x-ray image is of very poor quality, making it difficult to identify the reported fracture and signs of loosening.Additionally, the stem is not fully visible in the image.As a result, no useful information can be obtained from it.Given the early occurrence of this complication in the postoperative period, it is likely that osteointegration did not take place properly, which may have contributed to the mentioned fracture.Several factors could have influenced the failure of osteointegration, including the patient's biological characteristics.However, a definitive conclusion regarding the root cause of the failure cannot be drawn.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
Hip revision surgery on the right side performed at 3 months from the primary due to stem loosening and bone fracture caused by the loosening.No infection.No loosening of the acetabular components.The surgeon revised the stem, the head and the liner implanting a quadra stem cemented with a new ceramic ball and liner dm and performed a cerclage.

• Brand Name: MPRES NECK PRESERVING STEM
• Common Device Name: MPRES STEM LAT SIZE 9
• 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: 21420280
• Report Number: 3005180920-2025-00082
• Device Sequence Number: 18052792
• Product Code: LZO
• UDI-Device Identifier: 07630345713551
• UDI-Public: 07630345713551
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K210263
• 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): 02/20/2025

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: 01.37.029
• Device Lot Number: 2213852
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/20/2025
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 50 KG