MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 09/12/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was perform due to dislocation caused by a fall, a tandem, ox head and others were removed, and tandem, ox head implanted.

Manufacturer Narrative

It was reported that a revision surgery was perform due to dislocation caused by a fall.The associated devices, used in treatment, were not returned for evaluation.After repeated requests, smith and nephew has been unable to obtain device details.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 devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.It was reported that the physician does not believe this was a product defect.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.No further medical assessment can be rendered at this time.Probable causes of dislocation could include but not limited to trauma injury or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.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, this complaint will be reopened and reevaluated.

• Brand Name: HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9200126
• MDR Text Key: 162635594
• Report Number: 1020279-2019-03671
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention