MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-P COLLARED 01.18.440 AMISTEM-P COLLARED LAT STEM SIZE 0; HIP COLLARED STEM

Catalog Number 01.18.440

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/23/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 27-nov-2023 lot 2301284: (b)(4) items manufactured and released on 05-may-2023.Expiration date: 2028-04-17.No anomalies found related to the problem.To date, 1 item of the same lot has been sold.Clinical evalutaion performe dby medical affairs department: during primary tha in a young patient with very dense bone and narrow canal, the stem sat proud by several millimetres compared to the broached housing and the surgeon kept hammering to achieve correct leg length, but unfortunately this ended up in femoral fissure.The bone was cerclaged and the surgery carried out successfully.In case of very dense bone and narrow canal, it is possible that the final stem may sit proud compared to the broach: a minimum rotational mismatch between stem and broach can cause the final stem to follow a different path and get locked in the canal.It's a difficult situation, hard to forecast when planning.With the elements at hand, there is noreason to suspect faulty devices.

Event Description

When preparing the bone with the amistem broaches (same broaches for amistem-h) the size 0 broach was reached.It sat tight within the envelope of the femur.The medial aspect of the broach was on the cortical bone of the medial calcar as the planning indicated.Trial reduction was performed and the definitive stem was selected.On implanting the definitive stem, size 0 lateral amistem-p collared, the stem sat up approximately 5mm from the trial component position.The surgeon continued to impact the stem when he noticed a fracture on the antero medial wall of the calcar.A cable was used to reduce the risk of the fracture propagating further.The stem was not replaced or removed.

• Brand Name: STEM: AMISTEM-P COLLARED 01.18.440 AMISTEM-P COLLARED LAT STEM SIZE 0
• Type of Device: HIP COLLARED 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: 18356433
• MDR Text Key: 330889457
• Report Number: 3005180920-2023-01000
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630040720298
• UDI-Public: 07630040720298
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.18.440
• Device Lot Number: 2301284
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/05/2023
• 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: 45 YR
• Patient Sex: Female