MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 0; CEMENTLESS HIP STEM

Model Number	01.18.140
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 november 2020: lot 177152: (b)(4) items manufactured and released on 07-mar-2018.Expiration date: 2023-02-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager: femoral fracture detected 2 days after cementless total hip arthroplasty in an elderly woman ((b)(6) year old).We cannot tell if fracture occurred during or after surgery.During rehabilitation period, a sudden movement on a weakened bone due to normal femoral preparation may favour the occurrence of early fracture.There is no reason to suspect a faulty device.
Event or Problem Description
7 days after surgery femur fracture was noticed.The fracture was not noticed during surgery and it is unknown when it occur.Femur was successfully revised one week after primary surgery.
Event or Problem Description
2 days after surgery femur fracture was noticed.The fracture was not noticed during surgery and it is unknown when it occur.Femur was successfully revised 2 days after primary surgery.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 0
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10991774
• Report Number: 3005180920-2020-00891
• Device Sequence Number: 13651128
• Product Code: LZO
• UDI-Device Identifier: 07630030804168
• UDI-Public: 07630030804168
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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: 02/26/2023
• Device Model Number: 01.18.140
• Device Catalogue Number: 01.18.140
• Device Lot Number: 177152
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Weight: 70