MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 1; CEMENTLESS STEM

Model Number	01.18.141
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07.12.2021.Lot 124111: (b)(4) items manufactured and released on 14-jan-2013.Expiration date: 2017-12-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2017.Clinical evaluation performed by medical affairs director: 8.5 years after primary cementless tha, the stem is exchanged mainly because the limb is shorter.Reportedly, the patient suffered a fall 5 years before revision surgery, with fracture of the femour, and this likely caused stem subsidence and initial loosening.No reason to suspect a faulty device at the origin of this adverse event.
Event or Problem Description
At 8 years and 5 months after the primary surgery, revision surgery was performed.The patient had a fall around 2016 and nobody noticed that probably had a fracture in the femur, which may have caused the subsidence of the stem.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 1
• Common Device Name: CEMENTLESS STEM
• 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: 13074877
• Report Number: 3005180920-2021-01017
• Device Sequence Number: 12258385
• Product Code: LZO
• UDI-Device Identifier: 07630030804175
• UDI-Public: 07630030804175
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2021

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: 12/31/2017
• Device Model Number: 01.18.141
• Device Catalogue Number: 01.18.141
• Device Lot Number: 124111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2013
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White