MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE 1; HIP CEMENTED STEM

Model Number	01.18.151
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2021 lot 2009240: 55 items manufactured and released on 15-dec-2020.Expiration date: 2025-12-03.No anomalies found related to the problem.To date, 14 items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director: femoral canal perforation during tha surgery on an old lady with very thin and probably weak cortical bone.The bone strength was evidently not sufficient to properly guide the broach, because in spite of the smooth, rounded tip it still perforated the femoral canal.No reason to suspect a faulty device at the origin of this problem.
Event or Problem Description
After the insertion of the stem, femoral perforation was confirmed on the final checking x-ray.The surgeon decided to finish the surgery without any treatment.

• Brand Name: AMISTEM C CEMENTED STD STEM SIZE 1
• Common Device Name: HIP CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12015241
• Report Number: 3005180920-2021-00490
• Device Sequence Number: 4543693
• Product Code: LZO
• UDI-Device Identifier: 07630030804267
• UDI-Public: 07630030804267
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/17/2021

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: 04/04/2021
• Device Model Number: 01.18.151
• Device Catalogue Number: 01.18.151
• Device Lot Number: 2009240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/17/2021
• 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: 84 YR