MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG RT-PLUS TIBIAL INSERT 2/14MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 75005481

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, after a tka performed on (b)(6) 2020, the patient presented on (b)(6) 2021 with the rt-plus tibial insert 2/14mm broken.On (b)(6) 2021 a revision surgery was performed in order to resolve this problem.The current health status of the patient is unknown.

Manufacturer Narrative

Results of investigation: it was reported that, after a total knee arthroplasty performed on (b)(6) 2020, the patient presented on (b)(6) 2021 with the rt-plus tibial insert 2/14mm broken.The device, used in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could be confirmed.The returned insert is fractured at the distal end.Furthermore, the clamp used to fix the insert to the tibial plateau is broken as well.A macroscopic analysis of the insert fracture surface shows striations which indicate that the fracture originated on the posterior side.However, no fatigue striations are visible on the clamp fracture surface based on the performed microscopic analysis.The fracture surface shows signs of ductile overload.Furthermore, the edges of the fragments are rounded which indicates a movement under load between the two insert fragments after the fracture.A review of the complaint history was performed for the part number in scope.Similar complaints were identified.However, the occurrence is in line with the corresponding risk file.A review of the batch record revealed no deviations from the standard manufacturing process, that could have contributed to the reported issue.There is no indication that the device failed to match specification at the time of manufacturing.A review of past corrective actions was performed.No further escalation is required.A review of the device labeling revealed that the instructions for use states fracture of the component as a possible risk factor in combination with the implantation of a knee prosthesis.The concerning failure mode and the severity are covered in the concerning risk management file.Based on the performed medical investigation, the dislocation and fracture of the insert and clamp could be confirmed.In the revision operative report, it is noted that a week prior the revision surgery, the patient had a dislocation of the knee joint prothesis as part of a slipping trauma in the toilet chair and obviously the maneuver led to a dislocation of the insert.The provided x-rays were reviewed; however they do not contribute to the root cause of the dislocation and breakage of the tibial insert.They just confirm the event and dislocation.To sum up, it cannot be concluded that the reported events were associated with a malperformance of the implant.However, from the performed visual inspection it can be concluded that the fracture originated from the posterior side which indicates a hyperextension of the knee.Therefore, the acute fracture of the clamp and the inlay may have occurred at the same time when the patient luxated and potentially hyperextended his knee a week before the revision surgery.Based on the performed investigations, the relationship between the reported event and the device was confirmed and the probable cause for the fracture is attributed to a known inherent risk of the device.The need for corrective actions is not indicated.The returned part will be archived and smith+nephew will continue to monitor for similar issues.This investigation is considered closed.

Event Description

It was reported that, after a tka performed on (b)(6) 2020, the patient presented on (b)(6) 2021 with the rt-plus tibial insert 2/14mm broken.On (b)(6) 2021 a revision surgery was performed in order to resolve this problem.The current health status of the patient is good.

• Brand Name: RT-PLUS TIBIAL INSERT 2/14MM
• 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: 12601560
• MDR Text Key: 280074038
• Report Number: 9613369-2021-00384
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K021714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 75005481
• Device Lot Number: D1924350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2019
• 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): Hospitalization; Required Intervention; Other
• Patient Age: 82 YR
• Patient Sex: Female