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

Catalog Number 01.18.434

Device Problem No Apparent Adverse Event (3189)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/10/2023

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 329939131
• Report Number: 3005180920-2023-00981
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 01.18.434
• Device Lot Number: 2248423
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Race: White