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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM M LFT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM M LFT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 64811120
Device Problem Osseointegration Problem (3003)
Patient Problems Injury (2348); Inadequate Osseointegration (2646)
Event Date 05/04/2018
Event Type  Injury  
Manufacturer Narrative
Reported event: an event regarding loosening involving an mrh femoral component was reported. The event was not confirmed. Method & results: -product evaluation and results: not performed as no product was returned for evaluation. -clinician review: no medical records were received for review with a clinical consultant. -product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies. -complaint history review: there have been no other similar events for the lot referenced. Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided. Further information such as device return, pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause. It must be noted that the surgical protocol for mrh femoral components indicates that the mrh/duracon stem mates with the femoral component. The triathlon stem is not referenced in the implant listing in the surgical protocol. No further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened. Device not returned.
 
Event Description
As reported: "procedure: the patient had a complex history regarding his left knee. Had an index tka out of cors scope, then he had a neurological diagnosis that led to instability due to hyperextension. He had left knee revisions on (b)(6) 2017. All components exchanged. Now it was noted that the femoral component was loose and underwent second left knee revision on (b)(6) 2018. Longer stem and cone exchanged, patellar component retained. Some components in the second revision are off-label use".
 
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Brand NameMRH KNEE FEM M LFT
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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
joanne mahony
ida industrial estate
carrigtwohill NA
214532800
MDR Report Key7971087
MDR Text Key123938477
Report Number0002249697-2018-03392
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002552
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial
Report Date 10/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2021
Device Catalogue Number64811120
Device Lot NumberBAR2P
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2016
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: 10/16/2018 Patient Sequence Number: 1
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