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 09/17/2019

Event Type  Injury  

Event Description

It was reported that during revision surgery the constraint liner was replaced with a new constraint liner of the same size, given that the patient had dislocated several times previously.Back-up device available.

Manufacturer Narrative

It was reported that during revision surgery the constraint liner was replaced with a new constraint liner of the same size, given that the patient had dislocated several times previously.The affected device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.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 device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.No further medical assessment can be performed at this time.Possible causes of dislocation could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• 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: 9187466
• MDR Text Key: 162441941
• Report Number: 1020279-2019-03655
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention