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

Ref imp# (b)(4).

Manufacturer Narrative

Document review: amistem h cementless femoral stem size 2 lat: ref.01.18.142 / lot 121329 (b)(4): all parameters were found to be in accordance with the specs valid at the time of mfg, including washing and sterilization procedures.From the data collected, there are no evidences that the event is device related but it is highly likely due to a surgical mistake.

• 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 INTERNATIONAL, SA; strada regina 6874; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: adam gross ; 1556 w carrol ave.; chicago, IL 60607 ; 3128782381
• MDR Report Key: 3913753
• MDR Text Key: 17386275
• Report Number: 3005180920-2014-00071
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K093944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• 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
• Date Manufacturer Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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