MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number UNKNOWN

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

Patient Problem Insufficient Information (4580)

Event Date 12/09/2020

Event Type  Injury  

Event Description

It was reported that, according to the swiss national hip & knee joint registry annual report, about hip and knee replacement results between 2012 ¿2019, it was found that an unkn r3 shell was revised on 9 patients due to unknown reasons.Further information is not available.

Manufacturer Narrative

H6: the devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, this group of cases from the swiss national hip and knee joint annual report, from 2012 thru 2019 reporting surgeries performed on many components (hips and knees) for many causes.No medical documents or specific patient information has been provided.It has been communicated the no more information is available.Smith and nephew has not received the devices/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 product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.Based on this investigation, the need for corrective action is not indicated.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN R3 SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11132570
• MDR Text Key: 225563872
• Report Number: 1020279-2021-00190
• Device Sequence Number: 1
• Product Code: MBL
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• 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: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention