MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG RT-PLUS TIBIAL INSERT 4/14MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 75005484

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 02/20/2023

Event Type  Injury  

Event Description

It was reported that, after a tka surgery was performed on (b)(6), the patient experienced one revision surgery, on (b)(6) 2018 by cone fracture (covered under (b)(4)).The patient suffered from a second revision surgery, on (b)(6) 2023 due to a tibia inlay anchorage bar fracture and an inlay pin fracture and dislocation.During this revision surgery, a rt-plus tibial component 4 cemented and rt-plus tibial insert 4/14mm were exchanged.Patient's current health status is unknown.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that, after a second revision surgery had been performed on (b)(6) 2018 due to inlay cone fracture (covered under c-0198806), the patient required a third revision surgery on 20-feb-2023 due to a tibia inlay anchorage bar fracture and an inlay pin fracture and dislocation.During this revision surgery, a rt-plus tibial component 4 cemented and rt-plus tibial insert 4/14mm were exchanged.Patient's current health status is unknown.

Manufacturer Narrative

Additional information: b7 (patient's preexisting conditions), h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: it was reported that, after a second revision surgery had been performed on (b)(6) 2018 due to inlay cone fracture (covered under c-0198806), the patient required a third revision surgery on (b)(6) 2023 due to a tibia inlay anchorage bar fracture and an inlay pin fracture and dislocation.During this revision surgery, a rt-plus tibial component 4 cemented and rt-plus tibial insert 4/14mm were exchanged.The device used in treatment was not returned for investigation.As the device was not returned, a visual inspection will be performed based on 3 pictures provided by the complainant.As per the images provided, it shows that the tibial insert has a fracture on the base of the anchorage post and the fractured fragment is shown to be completely removed from the patient.No additional signs of structural damages are evident as per the images provided.No batch number was communicated so the document history review was not possible.Due to insufficient information it is not possible to perform a review of past corrective actions.As the batch number is unknown, it is not possible to perform a complaint history review at batch level, and the complaint history review based on the product number revealed no additional similar complaints.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.Insufficient information was made available to determine the revision of the instructions for use applicable to the device at the time of manufacturing.However, a review of the current revision was conducted and it revealed that the instructions for use (lit.No.12.24, ed.03/21) states "fracture, breakage" of the component as a "potential medical device problems" in combination with the implantation of a knee prosthesis.Given the complete lack of cement adherence, micro/macromotion and subsequent tibial component loosening cannot be ruled out as contributing factors to the eventual fracture of the tibial anchor and anteriorly disassociated components, as well as the patient¿s extensive revision history.It is unknown if patient comorbidities were contributing factors.The patient impact included the component loosening and dislocation/fracture in the presence of fractured tibial cement mantle and tibial radiolucencies and an anticipated post-surgical rehabilitation phase.Further patient impact could not be determined.No further medical assessment can be rendered at this time.The performed investigation does not lead to an accurately determined cause.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.There is no need for further actions because of the limited information provided.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.Corrected data: b5 (narrative), h6 (medical device problem code).

• Brand Name: RT-PLUS TIBIAL INSERT 4/14MM
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16577328
• MDR Text Key: 311659688
• Report Number: 9613369-2023-00126
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 75005484
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/20/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female