MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL STEM; FEMORAL CEMENTLESS STEM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2017 it was confirmed that product code, lot and date of the primary surgery are not available.On (b)(6) 2018 the medical affairs director made the following analysis: revision of femoral stem and head in primary cementless tha.Date of primary operation unknown.The one pre-revision xray supplied shows a subsided femoral stem with some osteolytic areas in gruen zone 2 and 6/7 (to a lesser extent).Also some eterotopic ossification in the lateral part of the joint.The causes for subsidence or osteolysis cannot be determined with the information at hand.No previous radiographs were supplied.The stem may be slightly undersized but this cannot be determined with one projection only.

Event Description

Revision due to stem subsidence.The primary surgery date is unknown.The surgeon revised the stem and the ball head.

• Brand Name: AMISTEM H FEMORAL STEM
• Type of Device: FEMORAL CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7206126
• MDR Text Key: 97764090
• Report Number: 3005180920-2017-00852
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 73