STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Catalog Number 1236-2-848 |
Device Problem
Scratched Material (3020)
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Patient Problem
Loss of Range of Motion (2032)
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Event Date 12/30/2015 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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It was reported that surgeon was doing a left total hip and upon implantation of devices, surgeon tested for range of motion and noticed the devices were not articulating as they should so surgeon removed components and implanted new components.Surgeon noted that upon removal of devices surgeon noticed that devices had scratches on the surfaces.Implant sheet will be provided but rep not sure about op reports, x-rays, etc.On (b)(6) 2016, the sales rep indicated that the surgeon trialed to the correct size and implanted the final mobile bearing implants.Upon completing a range of motion check, the surgeon noticed that the outer bearing would not articulate with the metal mdm liner.The surgeon removed the adm poly liner and head and noticed that the liner was severely scratched.He carefully implanted a new adm poly liner and head and experienced the same articulation issue.Additionally, upon dislocation of the hip to remove the components, he noticed that the surface of the second poly liner was severely scratched again.Therefore, the surgeon removed the mdm liner, poly and head and re-implanted with 40 mm fixed bearing and completed the case successfully.
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Manufacturer Narrative
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An event regarding a rom (range of motion) issue involving an adm liner was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: the adm liner was returned with the metal head inserted.Extensive scratches were observed on the articulating surface of the returned adm liner.These scratches are consistent with explantation damage.Dimensional inspection: a dimensional inspection could not be performed due to the extent of the damage to the articulating surface of the returned adm liner.However a review of the device history record confirmed that all 17 released devices are were dimensionally within specification as per igs-0029573.Functional inspection: a functional inspection was not performed as the event cannot be replicated.Medical records received and evaluation: a review by a clinical consultant noted: there are x-rays but only prior to arthroplasty that indicate severe degenerative changes in the hip consistent with the indication for surgery.There is a surgical report that documents the problems as outlined in the pi intake as well as above but provides no further clues to the cause of the problem.Based upon available information it is not possible to establish a root cause of failure for this event.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: a review by a clinical consultant concluded: based upon available information it is not possible to establish a root cause of failure for this event.If additional information become available, this investigation will be reopened.
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Event Description
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It was reported that surgeon was doing a left total hip and upon implantation of devices, surgeon tested for range of motion and noticed the devices were not articulating as they should, so surgeon removed components and implanted new components.Surgeon noted that upon removal of devices surgeon noticed that devices had scratches on the surfaces.Implant sheet will be provided but rep not sure about op reports, x-rays, etc.On january 5, 2016, the sales rep indicated that the surgeon trialed to the correct size and implanted the final mobile bearing implants.Upon completing a range of motion check, the surgeon noticed that the outer bearing would not articulate with the metal mdm liner.The surgeon removed the adm poly liner and head and noticed that the liner was severely scratched.He carefully implanted a new adm poly liner and head and experienced the same articulation issue.Additionally, upon dislocation of the hip to remove the components, he noticed that the surface of the second poly liner was severely scratched again.Therefore, the surgeon removed the mdm liner, poly and head and re-implanted with 40 mm fixed bearing and completed the case successfully.
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