MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED STD STEM SIZE 4; HIP STEM

Catalog Number	01.18.434
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05-dec-2023 lot 2248423: (b)(4) items manufactured and released on 27-apr-2023.Expiration date: 2028-04-04.No anomalies found related to the problem.To date, 26 items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
After the primary hip surgery, it was observed that the patient had sustained a femoral bone intra-op fracture, in particular the femur fractured during the impaction of the final implant.At about 2 months after the primary, the surgeon cabled the fracture and revised the stem and head and the surgery was completed successfully.
Additional Manufacturer Narrative
On (b)(6) 2023 the clinical evaluation has been performed: two months after the index surgery the patient was revised due to a fracture.According to report the fracture was originated intra-operatively and then, probably, it enlarged when load was consistantly applied.Intraoperative femoral fractures are known possible adverse events of total hip replacements, described and quantified in literature.They mainly depend on bone morphology and mechanical properties.In this case, there is no reason to suspect a malfunctioning device.
Event or Problem Description
After the primary hip surgery, it was observed that the patient had sustained a femoral bone intra-op fracture, in particular the femur fractured during the impaction of the final implant.Cables were placed to fix intraoperatively the fracture.At about 2 months after the primary, the surgeon cabled the fracture and revised the stem and head and the surgery was completed successfully.

• Brand Name: AMISTEM-P COLLARED STD STEM SIZE 4
• Common Device Name: HIP 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: 18282477
• Report Number: 3005180920-2023-00981
• Device Sequence Number: 6762005
• Product Code: LZO
• UDI-Device Identifier: 07630040720236
• UDI-Public: 07630040720236
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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: 01.18.434
• Device Lot Number: 2248423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2023
• 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: 61 YR
• Patient Sex: Female
• Patient Race: White