MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 52MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Model Number R3 3 HOLE HA CTD ACET SHELL 52MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 04/18/2020

Event Type  Injury  

Event Description

It was reported that patient had a left thr on (b)(6) 2020.Revision surgery was performed on (b)(6) 2020 due to infection.Shell, liner, stem and head were removed.The wound was debrided and irrigated and samples were sent to pathology.Cpcs tandem unipolar construct (1ho stem/53mm head/+4mm sleeve) inserted and used as first stage cement spacer.Wound irrigated and closed in layers as per standard technique.Pt will return to theatre for second stage operation when infection has cleared.

Manufacturer Narrative

It was reported that patient had a revision surgery performed due to infection.Shell, linear, stem and head were removed.Wound debrided and irrigated.Patient will return for second stage operation when infection has cleared.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.The device was sterilized according to sterilization release documentation from quality control.This reported failure has been identified in the instructions for use and risk management files as potential adverse events.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Thus no thorough investigation could not be performed.Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 3 HOLE HA CTD ACET SHELL 52MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10058883
• MDR Text Key: 191095581
• Report Number: 1020279-2020-01699
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: R3 3 HOLE HA CTD ACET SHELL 52MM
• Device Catalogue Number: 71331952
• Device Lot Number: 19LM03268
• Distributor Facility Aware Date: 04/18/2020
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention