In The News

The Attune® Knee System has been linked to early failure and revision surgery.


Unusually High Rate of Early Failure of Tibial Component in ATTUNE Total Knee Arthroplasty System at Implant–Cement Interface

A novel design total knee arthroplasty (TKA) system has been introduced to improve patient outcomes and increase longevity. However, we have encountered a high rate of debonding of tibial implant–cement interface. In addition, multiple reports have been filed in Manufacturer and User Facility Device Experience database (MAUDE) with the same mechanism of failure.

READ MORE at Thieme (The Journal of Knee Surgery)

Class 2 Device Recall Rotating Tibial Platform ATTUNE INTUITION Impactor

ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.

READ MORE at AccessData.FDA.gov

A comparison of patient reported outcome measures following total knee replacement with either the Depuy Synthes Attune™ or Depuy Synthes PFC™ total knee replacement systems

With the orthopaedic community and implant companies striving to improve outcomes following arthroplasty surgery by introducing new implants and adjusting design features of current implants, clinical trials are of increasing importance to not only ensure the safety of patients but also to provide accurate and longer term data on the longevity and function of the implants. The current study aims to assess for potential functional benefits in total knee arthroplasty using a robust randomised controlled trial and by utilising multiple functional and generic outcome measures with close follow up of the patient cohort.

READ MORE at OAText.com

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE FEMORAL IMPACTOR KNEE INSTRUMENT/TRIAL

The device associated with this report was not returned. The initial report stated the device would not be returned for evaluation. Expert opinion indicates that the failures are associated with environmental stress cracking (esc). The attune femoral impactor has been annealed to reduce residual stresses. Lab tests indicate significant reduction in residual stresses of annealed samples in comparison to un-annealed samples however a complete reduction in stresses is not achievable.

READ MORE at AccessData.FDA.gov

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