STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
|
Back to Search Results |
|
Catalog Number 5515-F-501 |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Pain (1994); Swelling (2091); Synovitis (2094); Injury (2348)
|
Event Date 07/17/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
The following other devices were added to this report after submission of the initial report: triathlon prim cem fxd bplt #5; cat# 5520b500; lot# elldb, triathlon symmetric x3 patella; cat# 5550-g-339; lot# e94r, triathlon ps x3 tibial insert; cat# 5532-g-511; lot# mnpl53, simplex p full dose 1 pack; cat# 6191-1-001; lot# rbv026.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was retained by the patient and was not returned to the manufacturer.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
|
Patient had an arthroplastic procedure done in (b)(6) 2015.The patient continues to have swelling and pain 6 months after his arthroscopy.
|
|
Manufacturer Narrative
|
An event regarding pain involving a triathlon femoral component was reported.The event was confirmed.Medical records received and evaluation: the provided medical records were reviewed by a clinical consultant on (b)(6) 2016.The clinical consultant noted that there was improper surgical technique at insertion of prosthesis related to extruded cement which was removed arthroscopic on (b)(6) 2015.The patient continues to have pain and swelling one year after his index tka and 6 months after two large cementophytes were removed arthroscopically.Two consultants at hospital for special surgeries(hss) found no immediate cause of his pain and recommended continue observation.To date, the knee does not appear to have been aspirated to rule out infection.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: although the patient had arthroscopic removal of extruded simplex p cement on the lateral aspect of the prosthesis, the exact cause of the reported pain could not be determined and the reported pain continues and the patient will have continued observation.Based on the medical review by the clinical consultant there is no evidence that the persistent swelling and pain are causally related to the design, manufacture, or materials of this prosthesis, but more likely result from the surgical technique, which created the extruded cement, secondary surgery, and persistent synovitis.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
|
|
Event Description
|
Patient had an arthroplastic procedure done in (b)(6) 2015.The patient continues to have swelling and pain 6 months after his arthroscopy.
|
|
Search Alerts/Recalls
|
|
|