MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TNDM BP SHL/XLPE LNR 47OD 26ID; FEMORAL COMPONENT

Catalog Number 71325047

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 10/08/2014

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to the patient falling causing a fracture and dislocation.

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

• Brand Name: TNDM BP SHL/XLPE LNR 47OD 26ID
• Type of Device: FEMORAL COMPONENT
• 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: lisa hassell ; 1450 brooks road; memphis, TN 38116 ; 9013991128
• MDR Report Key: 4201034
• MDR Text Key: 4979470
• Report Number: 1020279-2014-00666
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71325047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization