MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG RT-PLUS TIBIAL INSERT 6/11MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED,

Catalog Number 75005486

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

Patient Problem Failure of Implant (1924)

Event Date 03/31/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a revision surgery was performed due to remove the tibial insert.No more patient information was initially provided.

Manufacturer Narrative

It was reported that a revision surgery was performed.During this surgery, a patella was installed and the insert revised.The reason why this surgery was necessary in unknown.Since this revision surgery took place in 2016, the insert is not available for investigation.A second revision took place in 2020, which is documented in (b)(4) / 9613369-2020-00250.The batch number of the device, which intended use is treatment, was communicated.For the batch in scope, no further complaint was reported.The production documentation was reviewed.There are no indications that the insert failed to match specification at the time of manufacturing.The risk of a revision is covered through our risk management files.The ifu, lit no.12.24, ed.07/10 lists several risk factors and possible side effects which might lead to a revision surgery.As no medical documentation was provided, an assessment could not be performed.The root cause of the reported revision cannot be determined after investigation.To date, the need for further actions is not indicated.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor this device for further similar issues.

Event Description

It was reported that a revision surgery was performed.During this surgery, a patella was installed and the insert revised.The reason why this surgery was necessary in unknown.A second revision took place in 2020, which is documented in 9613369-2020-00250.

• Brand Name: RT-PLUS TIBIAL INSERT 6/11MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED,
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10913563
• MDR Text Key: 218494400
• Report Number: 9613369-2020-00249
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K021714
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/16/2019
• Device Catalogue Number: 75005486
• Device Lot Number: D1205186
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR