MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C FEMORAL STEMS; AMISTEM C CEMENTED STEM STANDARD SIZE 1

Model Number	01.18.151
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision at about 9 years and 8 months from the primary surgery due to stem loosening.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 08 august 2025.Lot 145434: (b)(4) items manufactured and released on 08-oct-2014.Expiration date: 31-august-2019.No anomalies were found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation: ten years after the implantation of a hybrid total hip arthroplasty, the cemented stem became mobilized and required revision.The radiographic image provided, likely taken before revision, shows a very peculiar situation, with a suffering bone (cause of disease: unreported), and a marked empty space near the tip of the stem in gruen zone 3/4, the origin of which cannot be determined from the available data.The cement mantle shows gross discontinuity and irregularity.The mobilization of the stem must have taken place progressively over a significant period of time, but no previous radiographs or reports of clinical status were supplied.With no radiographic and clinical history, no further analysis can be performed.It is very unlikely that the deterioration of the clinical condition may be related to a defect or malfunction of the implanted stem.Conclusions: although a certain root cause cannot be established, progressive deterioration of the patient's bone quality likely contributed significantly to the mobilization process.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 C FEMORAL STEMS
• Common Device Name: AMISTEM C CEMENTED STEM STANDARD SIZE 1
• 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: 22922930
• Report Number: 3005180920-2025-00811
• Device Sequence Number: 9162054
• Product Code: LZO
• UDI-Device Identifier: 07630030804267
• UDI-Public: 07630030804267
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 08/29/2025

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: 08/31/2019
• Device Model Number: 01.18.151
• Device Lot Number: 145434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2014
• 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: 78 YR
• Patient Sex: Female