MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT FULLY POROUS SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 71354233

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 03/01/2019

Event Type  Death  

Event Description

It was reported that the patient developed a chronic periprosthetic infection.After that, the patient had long term suppressive therapy.Then it was informed that the patient deceased (b)(6) 2019.

Manufacturer Narrative

The device, used in treatment was not returned for evaluation.Without the actual product, product evaluation could not be performed and complaint could not be confirmed.According to clinical/medical investigation, these cases from canada all report various adverse events with the redapt implants.All information available for this complaint case has been reviewed and considered in the medical assessment.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of complaint history revealed no prior complaints for the listed part.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.Credit will not be issued for the device.

• Brand Name: REDAPT FULLY POROUS SHELL 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10147983
• MDR Text Key: 194937511
• Report Number: 1020279-2020-02346
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K150790
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71354233
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/14/2020
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death