MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL STEMS; AMISTEM-H STD. SZIE 2

Model Number	01.18.132
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 july 2025.Lot 146951: (b)(4) items manufactured and released on 13-jan-2015.Expiration date: 2019-nov-11.No anomalies found related to the problem.To date, all the 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 revision surgery was performed approximately 9.5 years after the primary implantation of a tha, due to stem loosening.Radiographic evaluation revealed radiolucent lines, particularly around the proximal portion of the femoral stem.Distally, cortical thickening was noted at the stem tip, suggestive of adaptive bone remodeling.Aseptic loosening is a well-documented complication in the literature, often with multifactorial or unclear etiology.Even in this case, the precise cause of the failure remains difficult to determine based on the available information.Root cause: aseptic loosening is a possible literature-described adverse event after primary hip 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.
Event or Problem Description
Revision for stem loosening at about 9 years and 5 months post-primary.Stem and head revised successfully.No infection.No loosening of the acetabular shell.

• Brand Name: AMISTEM H FEMORAL STEMS
• Common Device Name: AMISTEM-H STD. SZIE 2
• 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: 22574586
• Report Number: 3005180920-2025-00685
• Device Sequence Number: 13182010
• Product Code: MEH
• UDI-Device Identifier: 07630030804083
• UDI-Public: 07630030804083
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 07/23/2025

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 Expiration Date: 11/11/2019
• Device Model Number: 01.18.132
• Device Lot Number: 146951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2015
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 74 KG