Catalog Number 5520-B-400 |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Pain (1994); Inadequate Osseointegration (2646)
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Event Date 11/14/2016 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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This pi is for the left knee.Patient's wife called stating her husband had bilateral knee replacements and reported pain and loosening.
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Event Description
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This pi is for the left knee.Patient's wife called stating her husband had bilateral knee replacements and reported pain and loosening.Patient would like to know if the implants and the shapematch cutting guide were involved in a recall update 10-july-2019: impression noted for left knee "radiographic findings are indicative of loosening of the tibial prosthesis.Certainly, an infection is in the differential diagnosis."patient notified that he is scheduled to have a left knee revision on (b)(6) 2019.
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Manufacturer Narrative
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The following devices were also listed in this report: unknown joint replacement_product; cat# unk jr; lot# unknown.Triathlon cr fem comp #5 l-cem; cat# 5510f501; lot# a9s4b.Triathlon asymmetric x3 patella; cat# 5551-g-299; lot# 6kkn.X3 triathlon cs ins size4 16mm; cat# 5531g416; lot# lek465.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding loosening and subsidence involving a triathlon baseplate was reported.The event was confirmed by medical review.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: review of these records confirm subsidence and loosening of the tibial component in a cemented left tka.The root cause for the loss of component fixation can not be established however the tibial component is undersized which may have been a contributing factor." product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: medical review concluded the following: review of these records confirm subsidence and loosening of the tibial component in a cemented left tka.The root cause for the loss of component fixation can not be established however the tibial component is undersized which may have been a contributing factor.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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Search Alerts/Recalls
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