MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA-DUMMY IMPLANT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event Description

Literature case in a scientific publication, zhang 2018, "optimizing stability in ao/ota 31-a2 intertrochanteric fracture fixation in older patients with osteoporosis" it was reported that a patient presented varus collapse of the femoral head and underwent a total hip replacement.

Manufacturer Narrative

It was reported from a literature study that a patient presented varus collapse of the femoral head and underwent a total hip replacement.The affected device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.Possible causes could include but not limited to mal-positioning of the implant or surgical technique.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: TRAUMA-DUMMY IMPLANT
• Type of Device: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9537021
• MDR Text Key: 173763767
• Report Number: 1020279-2019-04795
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention