MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US DELTA LINER 54MM OD; PRSTHSIS,HIP,SMI-CNSTRND,METAL/CRAMIC/CRAMIC/MTAL,CMNTDORUNCMNTD

Catalog Number 71325154

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Type  Injury  

Event Description

It was reported that patient suffered a dislocation after a primary left total hip arthroplasty.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.A review of the complaint history revealed no prior complaints for the listed lot.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Our clinical/medical team noted: without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: R3 36MM ID US DELTA LINER 54MM OD
• Type of Device: PRSTHSIS,HIP,SMI-CNSTRND,METAL/CRAMIC/CRAMIC/MTAL,CMNTDORUNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8196099
• MDR Text Key: 131394659
• Report Number: 1020279-2018-02891
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P150030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

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: Health Professional
• Device Catalogue Number: 71325154
• Device Lot Number: 17FT88297
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 11/26/2018
• Supplement Dates FDA Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 71 YR