MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN RT-PLUS OR RT-PLUS MODULAR IMPLANT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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

Patient Problem Hematoma (1884)

Event Date 09/02/2020

Event Type  Injury  

Event Description

It was reported that 5 patients were treated using smith and nephew rt-plus hinge prosthesis and 1 patient presented local hematoma which led to rehabilitation temporization and imposed rest, elastic bandages and cryotherapy.Patient was remitted spontaneously.

Manufacturer Narrative

Results of investigation: the study of vlad veringa et al [1] reports 5 cemented total knee prostheses type rotating-hinge rt-plus for patients with severe haemophilic arthropathy.2 patients showed wound healing problems which were treated successfully.This complaint will investigate the case which presented local hematoma which led to rehabilitation temporization and imposed rest, elastic bandages and cryotherapy.Patient was remitted spontaneously.The complaint device, used in treatment, was not received for investigation, a visual inspection could not be performed.The part and the batch number of the device is not known.Therefore, the batch record review and a complaint history review could not be performed.The device labeling were reviewed, the ifu for the complaint device (lit.No.12.24, ed.07/10) stated haematoma, wound haematoma and delayed wound healing among possible side effects resulting from knee arthroplasty.The severity and the failure mode are covered through our risk management.For medical investigation, the x-rays and photos within the study were reviewed; however, no specific patient identifier was given.Smith and nephew has not received adequate patient-specific documentation to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.It is noted the patient pain reduced considerably, excellent improvement of joint mobility and life quality.Based on our investigations the failure mode cannot be confirmed and the root cause of the problem stays undetermined due to insufficient information.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.[1]: veringa, vlad et al,; "constrained rotating hinge prostheses in severe haemophilic knee osteoarthritis"; materiale plastice, volume 55, no.4, 2018, pages 708-711, https://www.Revmaterialeplastice.Ro/pdf/veringa%204%2018.Pdf g1.

• Brand Name: UNKNOWN RT-PLUS OR RT-PLUS MODULAR IMPLANT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10611052
• MDR Text Key: 209340232
• Report Number: 9613369-2020-00190
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K023667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention