MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C 01.18.156 CEMENTED STD STEM SIZE 6; HIP CEMENTED STEM

Catalog Number	01.18.156
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 novemeber 2023 lot 2306000: (b)(4) items manufactured and released on 06-jun-2023.Expiration date: 2028-05-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: revision surgery almost a month after the primary cemented tha due to loosening of the stem.It may be possible that the interdigitation of cement in the bone did not achieve strong fixation.We cannot determine the causes of this condition, but we see no reason to think that the prosthetic implant was defective.From the radiographic images the femoral fracture it is not visible but during the surgery, it was repaired with cable and a plate.Analysis performed by r&d manager: looking at the image attached to the complaint it is visible the stem covered with patient blood.The femoral head is still connected with the stem taper some signs and scratches are visible both on the stem body and on the head probably due to revision surgery.From the image attached it is not possible to add other hypotesis of the stem failure, the root cause remains unknown.
Event or Problem Description
Revision surgery for cemented stem subsidence at about 1 month from the primary.During the surgery, a femoral bone fracture was found and repaired with cable and a plate.The stem and head have been revised successfully.

• Brand Name: STEM: AMISTEM C 01.18.156 CEMENTED STD STEM SIZE 6
• Common Device Name: HIP CEMENTED 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: 18356434
• Report Number: 3005180920-2023-01002
• Device Sequence Number: 17749078
• Product Code: LZO
• UDI-Device Identifier: 07630030804311
• UDI-Public: 07630030804311
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 12/19/2023

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 Catalogue Number: 01.18.156
• Device Lot Number: 2306000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2023
• 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: 87 YR
• Patient Sex: Female
• Patient Weight: 59 KG