MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN R3 SHELL; PROSTHESIS,HIP,HEMI-, TRUNNION-BEARING,FEMORAL,METAL/POLYACETAL

Catalog Number UNKNOWN

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

Patient Problem No Information (3190)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported in the study "midterm results of a contemporary, porous-coated acetabular system in patients undergoing primary total hip replacement for degenerative hip disease: a prospective, multicenter study", two hundred seventy-two adverse events (82.4%) were deemed not related to the study intervention, thirty five adverse events (10.6%) were possibly related, fourteen adverse events (4.2%) were probably related.Of the adverse events themselves, one hundred seventy seven (53.6%) were deemed mild, ninety five (28.8%) were moderate, and fifty five (16.7%) were severe.Most of the adverse events in the study were mild to moderate and usually resolved on their own and did not interrupt the subject¿s continuation in the study there is no specific information about what are the adverse events.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation, therefore the failure could not be confirmed.The clinical/medical team concluded, this complaint from canada and a literature review; "midterm results of a contemporary, porous-coated acetabular system in patients undergoing primary total hip replacement for degenerative hip disease: a prospective, multicenter study".Authors: ian r.Wilson, md, thomas r.Turgeon, md, mph, trevor c.Gascoyne, msc, peng, craig j.Della valle, md, richard w.Mccalden, md, mphil.The article reported fourteen adverse events (4.2%)that were probably related to the study however, there is no specific information about the adverse events.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Should 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: UNKNOWN R3 SHELL
• 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: 10388866
• MDR Text Key: 202337692
• Report Number: 1020279-2020-03835
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other