MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL STEMS; AMISTEM H CEMENTLESS STEM STANDARD SIZE 2

Model Number	01.18.132
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 october 2024.Lot 165563: (b)(4) items manufactured and released on 22-dec-2016.Expiration date: 2021-12-13.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 performed by medical affairs director a revision surgery was performed 7 years after the primary total hip arthroplasty due to stem loosening.During the revision, the acetabular cup was found to be stable.The available x-ray images clearly show radiolucent lines around the proximal stem and signs of stress shielding.Aseptic loosening is a known adverse event reported in the literature following primary cementless hip arthroplasties, though its causes are often unclear.In this case, the specific reason for the failure remains undetermined.Visual inspection performed by r&d project manager during the analysis it is evaluated that looking at the stem body an opaque white film is visible on the proximal part of the stem length.It is not possible to identify if this film is ha or bone residual, or a combined effect.Absorption of ha from the stem body can indicate that metabolic activity was taking place and that, presumably, adequate bone contact was achieved at the time of surgery.The post-op x-ray analysis could possibly provide more insight, such as the evaluation of possible initial stress-shielding some signs of minor damage and scratches are present on the neck of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue.Based on the analysis completed and information available, it is not possible to identify a root cause of the stem loosening reported.
Event or Problem Description
At about 7 years 5 months after the primary, the patient complained of thigh pain, and upon inspection, a radiolucent line was found to have developed and loosening occurred in the proximal part.It is supposed that distal locking of the stem had caused bone thickening, which had resulted in atrophy of the proximal part.The stem, cancellous bone screw, head and liner were revised.Because the cup was securely fixed, the screw was removed and not replaced.The amistem h was removed and an amis-c was implanted, and the thickened bone area was excavated with a flexible reamer.

• Brand Name: AMISTEM H FEMORAL STEMS
• Common Device Name: AMISTEM H CEMENTLESS STEM STANDARD SIZE 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: 20619234
• Report Number: 3005180920-2024-00925
• Device Sequence Number: 8792642
• Product Code: MEH
• UDI-Device Identifier: 07630030804083
• UDI-Public: 07630030804083
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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: 12/13/2021
• Device Model Number: 01.18.132
• Device Lot Number: 165563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2016
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian