MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 1; HIP FEMORAL STEM

Catalog Number	01.18.141
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 10 years and 9 months after primary, the patient has been revised because of aseptic loosening of the stem.The surgery has been completed successfully.
Additional Manufacturer Narrative
Batch review performed on 06-jun-2024, lot 104273: (b)(4) items manufactured and released on 10-feb-2011.Expiration date: 2016-01-31.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event since the release of this lot.Clinical evaluation revision 10 years and 9 months after primary tha due to aseptic loosening.From the radiographic image signs of stress shielding and radiolucent lines in gruen zones 1 and 7 are visible along with significant diaphyseal cortical hypertrophy.As former x-ray images are not available, the history cannot be reconstructed in detail.
Additional Manufacturer Narrative
Piece returned on 17 jul 2024 visual inspection performed bz r&d project manager: during the analysis it is evaluated the explanted stem.Some burns and scratches are present mainly on the neck part probably due to revision surgery.The stem titanium body is completely free of ha, as it is expectable after years of implantation.It is not possible to determine the root cause of reported complaint.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 1
• Common Device Name: HIP FEMORAL STEM
• 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: 19606725
• Report Number: 3005180920-2024-00460
• Device Sequence Number: 8204372
• Product Code: LZO
• UDI-Device Identifier: 07630030804175
• UDI-Public: 07630030804175
• 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: 2013
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 01/31/2016
• Device Catalogue Number: 01.18.141
• Device Lot Number: 104273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2011
• 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: 74 YR
• Patient Sex: Female