MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING, SIZE 6 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.176
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 18 august 2017 the medical affairs director performed a clinical evaluation and commented as follows: postoperative femoral fracture, few weeks after primary cementless tha.According to the report, no traumatic event occurred.Immediate postoperative fractures may be related to the normal bone weakening caused by the femoral preparation but also sudden or unexpected movements occurred during the re-education period may have contributed.In this case, there is no reason to suspect a malfunctioning device.Batch review performed on 28 august 2017.Lot 168238: (b)(4) items manufactured and released on 28 march 2017.Expiration date: 2022-03-20.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 came in complaining of pain.The patient fractured the femur bone.The cause of the fracture is unknown.The surgeon cabled the femur and revised the head and liner.The surgery was completed successfully.X-rays are available.Explants are not available.

• Brand Name: AMISTEM-H PROXIMAL COATING, SIZE 6 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6829713
• Report Number: 3005180920-2017-00481
• Device Sequence Number: 1600912
• Product Code: LZO
• UDI-Device Identifier: 07630030804410
• UDI-Public: 07630030804410
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

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: 03/20/2022
• Device Catalogue Number: 01.18.176
• Device Lot Number: 168238
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/30/2017
• 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