MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCURIS UNI KNEE SYSTEM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported the aseptic loosening of the implant and that patient has been in constant pain since the day of the operation.The device is accuris unicondular prothesis (medial).

• Brand Name: ACCURIS UNI KNEE SYSTEM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: claudia de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6180285
• MDR Text Key: 62538212
• Report Number: 1020279-2016-00963
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K912735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2016
• 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): Other
• Patient Age: 54 YR