MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG +4 XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71338554

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that patient suffered from a dislocation that had to be reduced 5 times.

Manufacturer Narrative

Results of investigation: the devices, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The devices were manufactured in 2017.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Our clinical / medical team noted: patient had a left hip replacement in 2009 due to arthritis and a revision in 2018.It was reported that in 2019 patient suffered from a dislocation that had to be reduced 5 times; however, to date no medical records have been received on this complaint.Without any supporting medical documentation, the reported event cannot be assessed, and a thorough medical assessment cannot be performed.In the event medical/clinical records are received, this complaint will be re-evaluated and a thorough medical assessment rendered.At this time a root cause could not be determined with the information provided.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 20 DEG +4 XLPE ACET LNR 36MM X 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9712882
• MDR Text Key: 179486994
• Report Number: 1020279-2020-00552
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598721
• UDI-Public: 03596010598721
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

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
• Device Model Number: 71338554
• Device Catalogue Number: 71338554
• Device Lot Number: 17DM01423
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention