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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #2 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #2 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C Back to Search Results
Catalog Number 5520B200
Device Problems Material Deformation (2976); Positioning Problem (3009)
Patient Problems Pain (1994); Swelling (2091); Injury (2348)
Event Date 04/28/2010
Event Type  Injury  
Manufacturer Narrative

An event regarding a size/fit issue involving a triathlon baseplate was reported. The event was confirmed through review of the provided medical records and x-rays by a clinical consultant. Method & results: device evaluation and results: visual inspection of the returned device indicates explantation damage is visible but no other relevant pathological findings are evident. Bone cement with adequate trabecular bone imprint would suggest that component fixation was adequate. Examination of the devices with material analysis engineer indicated not related to material integrity issue. Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: inadequate bone resection on the femoral side in combination with femoral component rotatory malposition, tibial baseplate posterior overhang, oblique patellar bone resection and choice for a relatively thick tibial bearing during primary arthroplasty have contributed to knee joint lengthening with stiffness of the knee and major functional impairment requiring revision. Device history review: all devices 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. Conclusion: the investigation concluded that inadequate bone resection on the femoral side in combination with femoral component rotatory malposition, tibial baseplate posterior overhang, oblique patellar bone resection and choice for a relatively thick tibial bearing during primary arthroplasty have contributed to knee joint lengthening with stiffness of the knee and major functional impairment requiring revision. It was reported that patient is inquiring if her implants are part of a recall. As per product recall verification response, it is confirmed that the reported device is not subject to a recall. 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 called and stated that she had a left tka on (b)(6) 2010. Patient stated that she experienced pain, swelling and stiffness since day on and never got better. Patient stated that she had a revision done on or about (b)(6) 2011. Update from clinician indicated inadequate bone resection on the femoral side, femoral component rotatory malposition, tibial baseplate posterior overhang, oblique patellar bone resection. Choice for a relatively thick tibial bearing.

 
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Brand NameTRIATHLON PRIM CEM FXD BPLT #2
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7480550
MDR Text Key107143408
Report Number0002249697-2018-01320
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 05/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/02/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2014
Device Catalogue Number5520B200
Device LOT NumberSNBSP
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/16/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/24/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/02/2018 Patient Sequence Number: 1
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