STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
|
Back to Search Results |
|
Catalog Number 5536B300 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
|
Patient Problems
Pain (1994); Injury (2348)
|
Event Date 11/25/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
|
|
Event Description
|
An uncemented right total knee was implanted (b)(6) 2015.Early post-operative x-rays revealed satisfactory component position.The patient reported continued pain.X-rays taken during subsequent visit revealed that the tibial component had subsided medially.Revision surgery was performed (b)(6) 2015.The tibial component was removed and replaced with a universal bp, cemented stem, and 10mm augments.The cemented patella and pa femur were determined to be well fixed and not revised.
|
|
Manufacturer Narrative
|
An event regarding tibial subsidence involving a tritanium bplate triathlon s3 was reported.The event was confirmed by medical review.Method & results: -device evaluation and results: the returned baseplate has evidence of explantation damage on the superior and inferior surfaces.The superior surface has some discolouration which may be attributed to the decontamination process.It is noted that there is little evidence of bone ingrowth.The device is otherwise unremarkable.-medical records received and evaluation: subsidence of an uncemented tibial component in an osteoporotic female patient is not unexpected.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.-device history review: review of the dhr was satisfactory.-complaint history review: chr confirmed that there are no other similar reported events for the lot.Conclusions: medical review has indicated that subsidence of an uncemented tibial component in an osteoporotic female patient is not unexpected however further information such as operative reports are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
|
|
Event Description
|
An uncemented right total knee was implanted (b)(6) 2015.Early post-operative x-rays revealed satisfactory component position.The patient reported continued pain.X-rays taken during subsequent visit revealed that the tibial component had subsided medially.Revision surgery was performed (b)(6) 2015.The tibial component was removed and replaced with a universal bp, cemented stem, and 10mm augments.The cemented patella and pa femur were determined to be well fixed and not revised.
|
|
Search Alerts/Recalls
|
|
|