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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ4 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ4 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5512-F-402
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Injury (2348)
Event Date 03/20/2019
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
It was reported that the patient's right knee was revised.As reported by rep: "this is a revision to a revision done on (b)(6) 2016 [(b)(6) 2016 revision was of competitor devices].The current revision was due to a suspected loose femoral component, as stated by surgeon".A size 4 ts femoral component with stem and augments, and a ts insert were revised to another size 3 ts femoral component with stem and stem extender, augments, and another ts insert.Rep provided implant sheets from current and previous revision, pre-revision x-rays, and reported that no further information will be available.
 
Manufacturer Narrative
An event regarding loosening involving a triathlon femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: the medical records were deemed insufficient for medical review.The clinician has stated - "need operative reports, office/clinical reports, serial x-rays, etc".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: it was reported that revision surgery took place due to loosening of the femoral components.The available medical records were provided to the consulting clinician who deemed it insufficient for a medical review.The event could not be confirmed with the information provided.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
 
Event Description
It was reported that the patient's right knee was revised.As reported by rep: "this is a revision to a revision done on (b)(6) 2016 [(b)(6) 2016 revision was of competitor devices].The current revision was due to a suspected loose femoral component, as stated by surgeon".A size 4 ts femoral component with stem and augments, and a ts insert were revised to another size 3 ts femoral component with stem and stem extender, augments, and another ts insert.Rep provided implant sheets from current and previous revision, pre-revision x-rays, and reported that no further information will be available.
 
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Brand Name
TRI TS FEMUR SZ4 RIGHT
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8520374
MDR Text Key142185152
Report Number0002249697-2019-01628
Device Sequence Number1
Product Code MBH
UDI-Device Identifier07613327026085
UDI-Public07613327026085
Combination Product (y/n)N
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2021
Device Catalogue Number5512-F-402
Device Lot NumberUBGE
Was Device Available for Evaluation? No
Date Manufacturer Received05/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age49 YR
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