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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 06/25/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed because patient had subluxed a number of times following surgery 3 months ago and dislocated for the first time when transferring onto surgical table yesterday.Doctor opened the hip joint using the previous incision.The head and liner were removed and a 20 degree trial liner used to assess stability.Surgeon still thought the joint was not sufficiently stable so progressed to removing the cup with explant.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.A review of complaint history for the listed parts revealed no prior complaints for this failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.No medical documents were received for investigation.Therefore no medical assessment can be performed.Without the actual product involved and/or device information, our investigation cannot proceed.If the devices or new information is received in the future, these complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• 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: sarah freestone ; 1450 brooks rd.; memphis, TN 38116
• MDR Report Key: 7713187
• MDR Text Key: 114797117
• Report Number: 1020279-2018-01365
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention