MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL STEMS; HA COATED STD STEM SIZE 2

Model Number	01.18.132
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review: as involved lot numers are unknown no investigation could be performed root cause: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event.
Event or Problem Description
At about 13 years and 9 months from the primary,the patient came in due to signs of an infection.The surgeon performed a revision of the femoral head, stem, acetabular cup, and liner.

• Brand Name: AMISTEM H FEMORAL STEMS
• Common Device Name: HA COATED STD STEM SIZE 2
• 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: 24208608
• Report Number: 3005180920-2026-00061
• Device Sequence Number: 13175227
• Product Code: MEH
• UDI-Device Identifier: 07630030804083
• UDI-Public: 07630030804083
• Combination Product (Y/N): N
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 01/29/2026

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: 01.18.132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 76 YR
• Patient Sex: Male