|
This pi is for the left knee.As reported in pi (b)(4): it was reported by surgeon that pre op x-rays showed medial compartment wear.All the standard criteria for medial compartment arthroplasty were fulfilled and surgeon performed a bilateral partial knee medial makoplasty.Primary surgery performed on (b)(6) 2017, by dr the surgeon reported that the cementing technique is as what he would do for all medial mako knees and have had no issues.Patient post op x-rays were good position.Even her post op mri done on her knees 9 months after post surgery showed no loosening and stable implants, nor edema.Post op x-rays showed the implants to be perfectly placed.However in 2019 it was noted that she developed accelerated loosening of both medial implants and this resulted in a bilateral revision total knee arthroplasty.The revision was performed by dr on (b)(6) 2019.The operative notes showed bilateral extensive polyethylene wear with resultant extensive synovitis and loosening.Revision performed using non stryker product.No details provided as patient went to consult another surgeon.Updated: 03 aug 2020 - refer implant picture in intake tab.Recently, the patient came back to visit and informed dr about the explant implant surgery done in year 2019.The surgeon informed stryker sales rep and would like stryker to investigate the possible causing of the loosening.Update: 6 aug 2020: it was informed by the surgeon that the patient wants to file a lawsuit against him.Additional information provided by the surgeon: i find this very peculiar.Photos of the retrieved implants show wear of the plastic that is way too advanced for a 2 year post op surgery.I wouldn¿t expect to see this much wear of the poly for that duration.Especially if the implants were well placed on post op x-rays.
|
|
This pi is for the left knee.As reported in (b)(4) : it was reported by surgeon that pre op x-rays showed medial compartment wear.All the standard criteria for medial compartment arthroplasty were fulfilled and surgeon performed a bilateral partial knee medial makoplasty.Primary surgery performed on (b)(6) 2017, by dr the surgeon reported that the cementing technique is as what he would do for all medial mako knees and have had no issues.Patient post op x-rays were good position.Even her post op mri done on her knees 9 months after post surgery showed no loosening and stable implants, nor edema.Post op x-rays showed the implants to be perfectly placed.However in 2019 it was noted that she developed accelerated loosening of both medial implants and this resulted in a bilateral revision total knee arthroplasty.The revision was performed by dr on (b)(6) 2019.The operative notes showed bilateral extensive polyethylene wear with resultant extensive synovitis and loosening.Revision performed using non stryker product.No details provided as patient went to consult another surgeon.Updated: 03 aug 2020 - refer implant picture in intake tab.Recently, the patient came back to visit and informed dr about the explant implant surgery done in year 2019.The surgeon informed stryker sales rep and would like stryker to investigate the possible causing of the loosening.Update : 6 aug 2020: it was informed by the surgeon that the patient wants to file a lawsuit against him.Additional information provided by the surgeon: i find this very peculiar.Photos of the retrieved implants show wear of the plastic that is way too advanced for a 2 year post op surgery.I wouldn¿t expect to see this much wear of the poly for that duration.Especially if the implants were well placed on post op x-rays.
|
|
Reported event:
it was reported, " this pi is for the left knee.As reported: it was reported by surgeon that pre op x-rays showed medial compartment wear.All the standard criteria for medial compartment arthroplasty were fulfilled and surgeon performed a bilateral partial knee medial makoplasty.Primary surgery performed on 21 may 2017, by doctor.The surgeon reported that the cementing technique is as what he would do for all medial mako knees and have had no issues.Patient post op x-rays were good position.Even her post op mri done on her knees 9 months after post surgery showed no loosening and stable implants, nor edema.Post op x-rays showed the implants to be perfectly placed.However in 2019 it was noted that she developed accelerated loosening of both medial implants and this resulted in a bilateral revision total knee arthroplasty.The revision was performed by doctor on 15 aug 2019.The operative notes showed bilateral extensive polyethylene wear with resultant extensive synovitis and loosening.Revision performed using non stryker product.No details provided as patient went to consult another surgeon.Updated: 03 aug 2020 - refer implant picture in intake tab.Recently, the patient came back to visit and informed doctor about the explant implant surgery done in year 2019.The surgeon informed stryker sales rep and would like stryker to investigate the possible causing of the loosening.Update : 6 aug 2020: it was informed by the surgeon that the patient want to file a lawsuit against him.Additional information provided by the surgeon: i find this very peculiar.Photos of the retrieved implants show wear of the plastic that is way too advanced for a 2 year post op surgery.I wouldn¿t expect to see this much wear of the poly for that duration.Especially if the implants were well placed on post op x-rays.¿
product evaluation and results:
review of the case session files was not performed as case session data was not provided.-clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated:
"pi - 2457135 and pi - 2412066 which is from singapore and relates to the right and left knees of the patient respectively.This is a female patient, dob 11/7/60 described as 146 cm tall and weighing 63 kg.Her date of implantation is listed as 5/21/17 and explantation 8/15/19.The event descriptions are identical with pi - 2457135 for the right and pi - 2452066 for the left knee.The event descriptions state: ".Bilateral medial uka.5/21/17.2019 loosening both medial implants.Bilateral revision tka.Bilateral extensive poly wear.Patient wants to file a lawsuit."
5/22/17 cytopathology report specimen received 5/19/17: "fluid from left knee" "loose bodies of fibrin with chondrogenesis and cartilage."
11/7/16 x-ray ap both knees "erect": mild osteoarthritis both medial compartments with lateral subluxation of both tibia.No clinical or pmh, no operative reports, no examination of explanted components, no post-operative or dated serial x-rays.Based upon the information available for review, neither confirmation of the event descriptions nor preparation of a medical report is possible for this case."
product history review
review of the device history records was not completed as the robot number/product information was not provided.Complaint history review
complaint history review was not performed as the robot and catalogue number was not provided.Conclusions:
the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the case session/log data, robot and catalogue information, operative reports, progress notes and pre- & post-op x-rays are needed to complete the investigation for determining root cause.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action:
a review of stryker¿s nc/capa database indicated there have been no ncs or capas associated with the product and failure mode reported in this event.H3 other text : device not returned.
|
