MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG RT-PLUS FEMORAL COMPONENT RIGHT 4 CEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 75005495

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

Patient Problem Injury (2348)

Event Date 09/10/2020

Event Type  Injury  

Event Description

It was reported that revision surgery was performed on (b)(6) 2020 due to pain, infection and loosening.Patient presented signs of inflammation, capsule formation around the cement mantle, the implant, porous bone.

Manufacturer Narrative

Results of investigation: it was reported that a revision surgery with the components rt-plus tibial component 4 cemented (art.No.75005505 / lot no.I1514882), rt-plus femoral component right 4 cemented (art.No.75005495 / lot no.L1508536) and rt-plus tibial insert 4/8mm (art.No.75005482 / lot no.D1513722) was performed due to pain, infection and loosening.Patient presented signs of inflammation, capsule formation around the cement mantle, the implant, porous bone.The complaint devices, used in treatment, were not returned for investigation.The reported failure mode could not be confirmed.The complaint history review was performed for all components of the revision surgery and no further complaints were reported for devices of the same production lot for any component.No deviations from the standard manufacturing process for all components were found which could have contributed to the reported issue, the sterilization certificates of all components were reviewed.The risk management review was performed for all components, the severity and the failure mode are covered through our risk management.The current ifu (lit.No.12.24, ed.10/05) describes that implant failures such as infection, pain and loosening of the implant have been reported and these are listed among the possible adverse events resulting from knee arthroplasty.For the medical investigation, the provided x-ray was reviewed and is consistent with the report.The implant has been loose for a while as there has been cortical changes that show where the femoral stem has been shifting.Smith+ nephew has not received device/adequate documentation to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further medical evaluation.Based on the conducted investigation, the root cause for the reported issue could not be determined conclusively.There are not any indications that the devices did not meet the specifications at the time of manufacturing.Should the parts be returned or more information become available, the investigation will be reopened.No actions are deemed necessary at this time.Smith+nephew will continue to monitor for similar issues.

• Brand Name: RT-PLUS FEMORAL COMPONENT RIGHT 4 CEM
• 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: 10645776
• MDR Text Key: 210379084
• Report Number: 9613369-2020-00199
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K003504
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2022
• Device Catalogue Number: 75005495
• Device Lot Number: L1508536
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 75005482, RT-PLUS INSERT, (B)(6). ; 75005505, RT-PLUS TIBIAL, (B)(6).
• Patient Outcome(s): Hospitalization; Required Intervention