MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL STEMS; AMISTEM H CEMENTLESS STEM LATERALIZED SIZE 4

Model Number	01.18.144
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to ha coated std stem loosening (osteointegration disorder), at about 8 years 5 months after primary.
Additional Manufacturer Narrative
Batch review performed on 21 october 2024.Lot 155238: (b)(4) items manufactured and released on 14-jan-2016.Expiration date: 2021-01-06.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 approximately 8 years after the primary total hip arthroplasty (tha) due to osteointegration disorders.Clinical details about the patient's status are not available.The x-ray images reveal signs of loosening, particularly in the proximal portion of the femoral stem, as well as evidence of stress shielding.Images of the explanted stem show extensive fibrous tissue around the mid-stem, confirming that osteointegration did not occur as expected.Aseptic loosening is a well-documented complication in cementless primary hip arthroplasties, with often unclear etiology.In this case, the exact cause of the failure cannot be determined.Investigation performed by r&d project manager.Looking at the images attached to the complaint it is visible the expianted stem covered with patient blood; extensive fibrous tissue around the mid-stem body is clearly visible from the images.Some minor signs and scratches are visible on the neck part probably due to revision surgery.The root cause is unknown.

• Brand Name: AMISTEM H FEMORAL STEMS
• Common Device Name: AMISTEM H CEMENTLESS STEM LATERALIZED SIZE 4
• 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: 20512075
• Report Number: 3005180920-2024-00866
• Device Sequence Number: 20603546
• Product Code: LZO
• UDI-Device Identifier: 07630030804205
• UDI-Public: 07630030804205
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 10/23/2024

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: 01/06/2021
• Device Model Number: 01.18.144
• Device Lot Number: 155238
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: White