MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 54MM; PRSTHSIS,HIP,SMI-CNSTRAIND,METAL/CRAMIC/CRAMIC/METAL,CMNTDORUNCMNTD

Catalog Number 71335554

Device Problem Insufficient Information (3190)

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

Event Date 11/26/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to recurrent dislocations of left total hip arthroplasty.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and without the primary implantation report, pre/post implantation x-ray, clinical documents we are unable to determine the root cause of the reported dislocations.In addition, without the implantation and pre-revision x-rays we are unable to determine the initial implant anatomical placement.However, based on the revision findings of a 15 degree decrease in the anteversion and 15 degree decrease in abduction, this cannot be ruled out as a likely contributory factor to the reported issue.The impact to the patient beyond the revision cannot be determined.No further clinical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 3 HOLE ACET SHELL 54MM
• Type of Device: PRSTHSIS,HIP,SMI-CNSTRAIND,METAL/CRAMIC/CRAMIC/METAL,CMNTDORUNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8194938
• MDR Text Key: 131367349
• Report Number: 1020279-2018-02889
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010598257
• UDI-Public: 03596010598257
• Combination Product (y/n): N
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2019

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: 71335554
• Device Lot Number: 18FW17438
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/25/2018
• Supplement Dates Manufacturer Received: 11/26/2018; 11/26/2018
• Supplement Dates FDA Received: 01/02/2019; 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCREW/LOT NUMBER:UNKNOWNSCREW/LOT NUMBER:UNKNOWN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 71 YR