MAUDE Adverse Event Report: Medacta International SA AMIStem H Femoral Stems; AMIStem-H Std. size 3

Model Number	01.18.133
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to stem loosening after about 13 years and 4 months from primary.The surgeon revised the medacta stem and head to a competitor stem and head, and revised the head biolox delta dia.28 12/14-l to a double mobility hc liner d 28/dmg.
Additional Manufacturer Narrative
Batch review performed on 04 september 2026 lot.125014: 30 items manufactured and released on 13 february 2013.Expiration date: 31 december 2017.No anomalies found related to the problem.To date, all items of the same lot have been sold, with no similar reported events during the period of review.Root cause:aseptic loosening 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, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: AMIStem H Femoral Stems
• Common Device Name: AMIStem-H Std. size 3
• 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: 50692312
• Report Number: 3005180920-2026-00925
• Device Sequence Number: 13160553
• Product Code: LZO
• UDI-Device Identifier: 07630030804090
• UDI-Public: 07630030804090
• Combination Product (Y/N): N
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 12/31/2017
• Device Model Number: 01.18.133
• Device Lot Number: 125014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2013
• 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: Male