MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL CEMENTLESS STEM SIZE 5 STD

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Please refer importer report#: (b)(4).

Manufacturer Narrative

Document review: amistem h cementless femoral stem size 5 std: ref.01.18.135/ lot# 132148 ((b)(4) stems produced/ (b)(4)sold): no anomalies found.Amistem h broch size 8: ref.01.18.10.105/ lot# 1212263 ((b)(4) reusable broaches produced): no anomalies found.Stem extractor: code 01.15.10.0038 - lot# 1110203 ((b)(4) reusable extractors produced): no anomalies found.From the data collected, there are no evidences that the event is device related.Similar case to mdr # 2014-00154, with the same surgeon.

• Brand Name: AMISTEM H FEMORAL CEMENTLESS STEM SIZE 5 STD
• Type of Device: FEMORAL CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; castel san pietro ; SZ
• Manufacturer (Section G): MEDACTA INTERNATIONAL, SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: adam gross ; 1556 w carrol ave.; chicago, IL 60607 ; 3128782381
• MDR Report Key: 4297159
• MDR Text Key: 20656550
• Report Number: 3005180920-2014-00155
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1