MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE 2; HIP CEMENTED STEM

Model Number	01.18.152
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation: during a total hip replacement surgery, a tibial fracture occurred while the surgeon was checking range of motion and stability.The leg was held by the amis leg positioner.The leg positioner is a passive device, no force is applied to the patient body except what is given by the operator.No details were supplied as to the rotation given, or other unusual situations that may help us understand the event.Looking at the radiograph, the patient appears to have thin tibial cortices, and therefore, a weak tibial bone.No evidence of a faulty device contributing to the adverse event could be found so far.Other device involved in the event: amis 01.15.10.0190 amis mobile leg positioner 2.0 frame; batch review performed on 4 november 2020; lot 1414812: (b)(4) item manufactured, and released on 17-apr-2015.No anomalies found related to the problem.
Event or Problem Description
The hip surgery went well, but the surgeon had noted a discrepancy when he tried to do an external knee rotation with the amis extension table, and when checked the mobility of the leg there was a crack, which leads to a tibial fracture visible by an image intensifier; a plate and screw were posed.No further operation was needed to recover this incident.The patient already had a medical history of a knee prothesis (date and devices used unknown).

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE 2
• Common Device Name: HIP CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10822497
• Report Number: 3005180920-2020-00796
• Device Sequence Number: 11497553
• Product Code: LZO
• UDI-Device Identifier: 07630030804274
• UDI-Public: 07630030804274
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2025
• Device Model Number: 01.18.152
• Device Catalogue Number: 01.18.152
• Device Lot Number: 2005322
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/11/2020
• 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: Other
• Patient Age: 76 YR
• Patient Weight: 64