MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED HA COATED STEM SIZE 2 LAT; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.242
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 october 2017.Lot 170053: (b)(4) items manufactured and released on 14 april 2017.Expiration date: 2022-03-30.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
The patient alleged the pain.After examination the surgeon found that the femoral distal anterior part was broken.The patient was hospitalized.Revision surgery was planned.

• Brand Name: AMISTEM COLLARED HA COATED STEM SIZE 2 LAT
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6990436
• Report Number: 3005180920-2017-00631
• Device Sequence Number: 13732400
• Product Code: LZO
• UDI-Device Identifier: 07630030804670
• UDI-Public: 07630030804670
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2017

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: 03/30/2022
• Device Catalogue Number: 01.18.242
• Device Lot Number: 170053
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/31/2017
• 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