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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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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.
 
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Brand Name
TRITANIUM BPLATE TRIATHLON S3
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5310197
MDR Text Key33861115
Report Number0002249697-2015-04308
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/25/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2020
Device Catalogue Number5536B300
Device Lot NumberCTD5546
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient Weight73
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