MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE1; HIP STEM CEMENTLESS

Model Number	01.18.231
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director.Intraoperative or immediate postoperative femoral calcar fracture detected few days after primary surgery in a (b)(6) year old woman.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.Also, during rehabilitation period, a sudden movement on a weakened bone due to normal femoral preparation may favour the occurrence of early fracture.The cause of this event cannot be determined however, there is no reason to suspect a faulty device.Batch review performed on 04 november 2021.Lot 1900042: (b)(4) items manufactured and released on 17-apr-2019.Expiration date: 2024-mar-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without similar reported event.
Event or Problem Description
About 1 week after the primary surgery, the surgeon noticed on the x-ray that a greater trochanteric fracture is visible, and performed osteosynthesis using a plate and wire.The surgery was completed successfully.The cause of the fracture is unknown, but it may have occurred during external rotation of the femur or when using a starter reamer or rasp.The bone quality was not good.

• Brand Name: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE1
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12852043
• Report Number: 3005180920-2021-00911
• Device Sequence Number: 4265555
• Product Code: LZO
• UDI-Device Identifier: 07630030804564
• UDI-Public: 07630030804564
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 11/22/2021

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: 03/16/2024
• Device Model Number: 01.18.231
• Device Catalogue Number: 01.18.231
• Device Lot Number: 1900042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2019
• 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: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian