MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED LAT STEM SIZE 4; HIP CEMENTLESS STEM

Model Number	01.18.444
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Right after the primary hip surgery, when the patient was in post-op recovery, the patient sustained a femoral fracture.It is unknown how this fracture occured.The patient was revised 1 day after the primary surgery.The surgeon revised the medacta stem and head to competitor components and revised the medacta liner with a medacta liner.The surgery was completed successfully.Bone quality normal.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023: lot 2209833: 10 items manufactured and released on (b)(6) 2022.Expiration date: 2027-aug-23.No anomalies found related to the problem.To date, 6 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: AMISTEM-P COLLARED LAT STEM SIZE 4
• Common Device Name: HIP CEMENTLESS 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16311508
• Report Number: 3005180920-2023-00032
• Device Sequence Number: 15190257
• Product Code: LZO
• UDI-Device Identifier: 07630040720335
• UDI-Public: 07630040720335
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

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 Model Number: 01.18.444
• Device Catalogue Number: 01.18.444
• Device Lot Number: 2209833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Female