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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH AXLE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STRYKER ORTHOPAEDICS-MAHWAH MRH AXLE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 6481-2-120
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994)
Event Date 03/04/2021
Event Type  Injury  
Manufacturer Narrative
Reported event: an event regarding allergy/reaction and osteolysis involving a mrh axle was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.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 relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: the event could not be determined because insufficient information was provided.Further information such as return of the device, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Not available.
 
Event Description
A patient specific solutions request was received for the patient's right distal femur with notes: "underwent constrained tka with stryker components and after initial postop period of doing well has had persistent osteolysis, pain and decreasing function.Allergy testing revealed nickel allergy and multiple blood and aspirations of the joint have been negative for infection." a nickel free distal free femur implant is being requested with a planned date of surgery (b)(6) 2021.Update: "the reason for revision is metal sensitivity".
 
Manufacturer Narrative
Reported event: an event regarding allergy/reaction and osteolysis involving a mrh axle was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.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 relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: the event could not be determined because insufficient information was provided.Further information such as return of the device, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
A patient specific solutions request was received for the patient's right distal femur with notes: "underwent constrained tka with stryker components and after initial postop period of doing well has had persistent osteolysis, pain and decreasing function.Allergy testing revealed nickel allergy and multiple blood and aspirations of the joint have been negative for infection." a nickel free distal free femur implant is being requested with a planned date of surgery (b)(6) 2021.Update: "the reason for revision is metal sensitivity.".
 
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Brand Name
MRH AXLE
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key11691469
MDR Text Key246454786
Report Number0002249697-2021-00704
Device Sequence Number1
Product Code KRO
UDI-Device Identifier07613327045253
UDI-Public07613327045253
Combination Product (y/n)N
PMA/PMN Number
K002552
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2023
Device Model Number6481-2-120
Device Catalogue Number64812120
Device Lot NumberCTD32337
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/25/2021
Initial Date FDA Received04/19/2021
Supplement Dates Manufacturer Received04/09/2021
Supplement Dates FDA Received04/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age19 YR
Patient Weight53
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