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

Model Number	01.18.152
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 april 2020: lot 1907509: (b)(4) items manufactured and released on 12-feb-2020.Expiration date: 2025-02-01.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.
Event or Problem Description
After the insertion of the stem, the surgeon checked and discovered the perforation at the distal side of the stem at ct image.The surgeon was able to retrieve the stem, but the surgeon was not able to retrieve the bone cement completely.The surgery finished without implanting the femoral stem.Total surgery time was 4.5 hours.2.5 hours delay.The soft tissues were hard.Revision surgery is planned, but the detail is unknown at the moment.

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE 2
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10031941
• Report Number: 3005180920-2020-00272
• Device Sequence Number: 14131733
• Product Code: LZO
• UDI-Device Identifier: 07630030804274
• UDI-Public: 07630030804274
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2020

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: 02/01/2025
• Device Model Number: 01.18.152
• Device Catalogue Number: 01.18.152
• Device Lot Number: 1907509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 05/07/2020
• 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: Required Intervention
• Patient Age: 81 YR