MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 56MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71331956

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 05/10/2018

Event Type  Injury  

Event Description

Revision surgery due to recurrent dislocation.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical analysis indicated that no clinical information has been provided for inclusion in is investigation.According to the surgeon¿s statement, ¿he felt the acetabular component may have been implanted with insufficient ante version and that coupled with the patient's unusual gait (he is a below knee amputee on the non-operative side) he may be more prone to dislocate posteriorly.¿ however, a review of the x-ray concluded that they don¿t appear to be too ante-verted.It doesn¿t appear to have changed positions or a failure of the cup or movement.The impact to the patient beyond the revision cannot be concluded.No further clinical/medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed parts revealed no prior complaints for the listed batches.Without the actual product involved our investigation cannot proceed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If the devices are received in the future, this complaint can be re-opened.We consider this complaint closed.

• Brand Name: R3 3 HOLE HA CTD ACET SHELL 56MM
• 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: 7564071
• MDR Text Key: 109882115
• Report Number: 1020279-2018-01052
• 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: 02/10/2019

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: Lay User/Patient
• Device Catalogue Number: 71331956
• Device Lot Number: 17FM20171
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 06/03/2018
• Supplement Dates Manufacturer Received: 05/11/2018
• Supplement Dates FDA Received: 02/10/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention