|
An event regarding a revision involving a metal head was reported.Disassociation was confirmed following a review of the available medical records and an x-ray with a clinical consultant.Device evaluation and results: visual inspection was performed as part of the material analysis report (mar).The report noted the following: damage was also observed on the taper of the head, likely from interacting with the trunnion of the accolade stem a material analysis report concluded: damage was observed on the accolade trunnion and v40 head taper.This damage was consistent with wear mechanisms due to the head taper and accolade stem trunnion losing their taper lock.No root cause of the loss of taper lock could be determined.[.] no material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: a review by a clinical consultant noted: there is a primary arthroplasty report from 2006 that confirms an adequate implantation without reported issues.The revision surgery report of 2016 documents the findings of severe trunnion damage with metallosis in the tissues observed and metallic particulate reported by the pathologist in the retrieved tissues.The revision surgery report has no details about potential factors contributing to the problem and mainly deals with the technicalities of component exchange to a restoration modular stem with mdm cup.There is one ap x-ray post event that also confirms visible trunnion damage with substance loss beyond the evident femoral head disassociation with the femoral head retained in the acetabular liner.Unfortunately, no lateral x-ray is available to crosscheck anteversion with the patient¿s native anatomy.Given the radiological findings, there are no clear procedure-related factors evident to contribute to the problem while from the patient-related perspective there is also limited information although body weight is normal.Device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.A review by a clinical consultant concluded: based upon available information, it is not possible to solve this case.More radiological and clinical information is required.No further investigation for this event is possible at this time.Further information such as pathology reports, additional x-rays as well as patient history and follow-up notes are required to investigate further.If additional information becomes available, this investigation will be reopened.
|
|
Took the accolade 1 stem out and went back with a rest mod and an mdm liner and head.Update per medical review: "on (b)(6)2013 she was seen in an emergency room visit for pain in the right hip of twenty-four hours duration and it was noted, "fell on right side yesterday.X-ray right: periprosthetic acetabular fracture.Treat: non-weightbearing with a walker.On (b)(6)2016 a revision right total hip arthroplasty, including the femoral stem, head and acetabular liner was performed for a post-operative diagnosis of "broken internal prosthesis right hip.X-ray of (b)(6)2016 is an ap pelvis demonstrating disassociation of femoral trunnion from arthroplasty head which remains in the acetabulum.Trunnion deformity is noted.".
|
|
Corrected data: d4 lot #, d4 expiration date; h4 device manufacture date.Additional information: b5 executive summary; h7 remedial action initiated; h9 correction/removal rpt number.An event regarding disassociation and metallosis involving an metal head was reported.Disassociation was confirmed, however, metallosis was not confirmed.Method & results: -device evaluation and results: visual inspection was performed as part of the material analysis report (mar) and noted: "damage was observed on the accolade trunnion and v40 head taper.This damage was consistent with wear mechanisms due to the head taper and accolade stem trunnion losing their taper lock.Damage was observed on the distal rim of the insert, consistent with contact against the stem.Scratches were observed on the insert, which is a common damage mode of uhmwpe.Yellow discoloration consistent with absorption of synovial fluid was also observed on the insert.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: a review of the provided medical records by a clinical consultant revealed: "on (b)(6)2013 she was seen in an emergency room visit for pain in the right hip of twenty-four hours duration and it was noted, "fell on right side yesterday.X-ray right: periprosthetic acetabular fracture.Treat: non-weightbearing with a walker.X-ray: total hip arthroplasty acceptable alignment, well-fixed, pubic ramus fracture near anatomic alignment.On (b)(6)2016 the patient was admitted and noted to be pain-free right total hip since the surgery in 2007.She was now noted to be 68-inches tall, weighing 107.9 kilograms, and stated that" on (b)(6)2016.Going from a sitting to a standing position noted immediate pain and a pop in her right hip and was unable to ambulate".X-ray notes, "hardware failure".X-ray of her right hip demonstrated a fracture through the trunnion.On (b)(6)2016 a revision right total hip arthroplasty, including the femoral stem, head and acetabular liner was performed for a post-operative diagnosis of "broken internal prosthesis right hip".The operative report describes general anesthesia and a posterolateral approach.The operative report noted, "synovitis with metallosis throughout joint.Stem well-fixed.Removed with midas rex and flexible osteotomes; removed poly insert.Frozen section negative for infection.Reamed femur to 17 for a 17/155 restoration modular conical stem".A 23/0 cone body, a 28/0 biolox v-40 head, and a 28/52 size 46 f adm/mdm x3 insert were inserted by uncomplicated surgery.The patient was subsequently discharged on (b)(6)2016.The surgical pathology note for a frozen section of synovium notes, "particle deposition disease.No evidence of infection".An office visit note of july 12, 2016 states, "staples removed.Pleased with progress.X-ray: excellent alignment".When seen on (b)(6)2016 it was noted, "right hip pain improving.X-ray unchanged.Pleased with progress." no documented follow-up subsequent to this visit is available.X-ray of (b)(6)2016 is an ap pelvis demonstrating disassociation of femoral trunnion from arthroplasty head which remains in the acetabulum.Trunnion deformity is noted and the acetabular shell and femoral stem are unchanged.An x-ray dated (b)(6)2016 shows the same acetabular shell, but a restoration modular long-stem revision femoral component.The hip is reduced and in nominal position.Based upon the information available for review, no determination can be made regarding the cause of the "broken internal prosthesis" noted as the diagnosis in the revision operative report of (b)(6)2016.-device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the event of disassociation was confirmed and the root cause was determined to be the head taper and stem turnnion losing their taper lock.This was confirmed via medical review and material analysis.Medical review notes: "x-ray of (b)(6)2016 is an ap pelvis demonstrating disassociation of femoral trunnion from arthroplasty head which remains in the acetabulum." and material analysis concluded: "damage was observed on the accolade trunnion and v40 head taper.This damage was consistent with wear mechanisms due to the head taper and accolade stem trunnion losing their taper lock." the subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall (b)(4).Was initiated for the lfit v40 cocr heads within scope of nc and capa.
|
