MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL CEMENTLESS STEM SIZE 2 LAT

Catalog Number 01..18.142

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Pain (1994)

Event Date 05/13/2014

Event Type  Injury  

Event Description

The pt was complaining of pain about a year post-op.After review of the pt's x-rays, the surgeon realized he implanted too small of a femoral stem and he felt the acetabular cup needed better placement.A revision surgery was performed.Ref mfr # 3005180920-2014-00071.

• Brand Name: AMISTEM H FEMORAL CEMENTLESS STEM SIZE 2 LAT
• Type of Device: FEMORAL CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; castel san pietro ; SZ
• Manufacturer (Section G): MEDACTA USA INC.; 1556 w carroll ave; chicago IL 60607 000
• Manufacturer Contact: 1556 w carroll ave; chicago, IL 60607-0000
• MDR Report Key: 3913836
• MDR Text Key: 4582193
• Report Number: 3006639916-2014-00071
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/10/2014

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
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 01..18.142
• Device Lot Number: 121329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2014
• Distributor Facility Aware Date: 05/14/2014
• Device Age: 23 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention