Please note the correction statement regarding d9/h3, h6 method code: the reported event was confirmed, since the device was returned for evaluation, and matches the alleged failure.The device inspection revealed the following: a visual inspection revealed the returned implant (dwx934) has multiple surface scratches where the poly portion is inserted into the device.There are also noticeable scratches around the upper ring of the device.Additionally, significant fretting was noted on the post that mates with the humeral component of the prothesis.Functional inspection: a functional inspection of the spacer could not be performed due to the risk of damage the poly insert component would incur in order to successfully separate the spacer from the poly.A review of the labeling and device history for the reported lot did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Since data were provided, the opinion of a medical expert was sought and stated as following: ¿knowing the patient¿s history with implant stability issues, should he be chopping wood and carrying it with his affected arm? would this be ¿non-compliance¿ on his part? patients should be informed by their hcp that a shoulder arthroplasty does not compare to a normal native shoulder joint.They should be informed that overloading (carrying weights, manual labor and certain types of sports) may influence the lifetime of the device.I conclude that chopping wood and carrying wood may jeopardize the service life of the implant.Could the event have been caused by improper technique used by the surgeon?? (again, i know this is difficult to answer due to the fact that we do not have any x-rays to review.) the patient had an unstable shoulder, meaning insufficient soft tissue tensioning and/or issues with the position of the device.The surgeon tried to solve the problem by adding polyethylene thickness (exchanged for thicker poly insert), which will cause higher stresses on the polyethylene.The damage on the pe-liner may be the result of impingement, adding more forces that may dislodge the liner.Yes, technical procedure related issues may have been a causative factor.X-rays could be helpful in that.Are there any other contributing factors for this event that i am overlooking? see the above answers.¿ based on the investigation, the root cause was attributed to a patient related complication not related to the implanted device.If any additional information is provided, the investigation will be reassessed.
|