MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C FEMORAL STEMS; AMISTEM C CEMENTED STEM LATERALIZED SIZE 7

Model Number	01.18.107
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 8 years 7 months after the primary, the patient came in reporting pain due to a loose stem and the cause is unknown.The surgeon revised the medacta stem and head to competitor components and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 25 august 2025.Stem: amistem c 01.18.107 amistem-c lat.Size 7 (k103189) lot 157364: (b)(4) items manufactured and released on 16-march-2016.Expiration date: 2021-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation 8.5 years after primary hybrid tha the stem becomes loose.There is basically no information on this case and the quality of the one radiograph supplied is poor.Cement mantle appears to be detached from the bone, but with no history no useful comment can be made.We ought to categorize this case as aseptic loosening, but no further comment can be offered with the information at hand.Conclusion: 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.

• Brand Name: AMISTEM C FEMORAL STEMS
• Common Device Name: AMISTEM C CEMENTED STEM LATERALIZED SIZE 7
• 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: 23001778
• Report Number: 3005180920-2025-00847
• Device Sequence Number: 8806767
• Product Code: LZO
• UDI-Device Identifier: 07630030803857
• UDI-Public: 07630030803857
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2025

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: 01/31/2021
• Device Model Number: 01.18.107
• Device Lot Number: 157364
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2016
• 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
• Patient Race: White