Model Number AE-QAS-K521-99 |
Device Problems
Material Fragmentation (1261); Unstable (1667); Patient-Device Incompatibility (2682)
|
Patient Problems
Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Pain (1994)
|
Event Date 03/19/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
|
|
Event Description
|
It was reported that there was an issue with as enduro femoral component.The pre-operative diagnosis in 2017 was multi-directional instability following the primary knee with a nickel allergy of the left knee and left knee pain.The patient was initially implanted with enduro components on (b)(6) 2017.All components were cemented one-on-one with tobramycin placement of stimulan pellets with 240mg of tobramycin follow by 100mg of vancomycin per mixture.There later was a failed left total knee, revision secondary to wear and debris of left knee on (b)(6) 2020, and there had been increased pain noted prior to surgery.A revision surgery was necessary.The implant that was revised was the aesculap enduro femur.A porex component from link with niobium was used instead.Additional information was requested.The adverse event is filed under xc (b)(4).
|
|
Event Description
|
No update.
|
|
Manufacturer Narrative
|
Section d: leading material updated.
|
|
Event Description
|
No update.
|
|
Manufacturer Narrative
|
Investigation: no product at hand, therefore an investigation at the devices is not possible.Batch history review: a review of the device quality and manufacturing history records is not possible because the material number as well as the batch number is unknown.Conclusion and root cause: based on the information available it is not possible to determine a definitive root cause for the failure at that time.Rationale: on the basis of the current information and without a product for investigation, a clear conclusion/root cause for the implant loosening can not be drawn.At that time it is not possible to verify if the black staining/debris is responsible for the implant loosening.There are many potential sources regarding to implant loosening: modification/ change in the surgical technique.Cement technique; patient fall; patient allergy/infection.Corrective action: product safety case was created.
|
|
Search Alerts/Recalls
|