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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK BUMPER INSERT - NEUTRAL PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STRYKER ORTHOPAEDICS-MAHWAH MRHK BUMPER INSERT - NEUTRAL PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 6481-2-130
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994)
Event Date 03/04/2021
Event Type  Injury  
Manufacturer Narrative
Reported event. An event regarding osteolysis involving a mrh bumper 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 NameMRHK BUMPER INSERT - NEUTRAL
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
EI NA
Manufacturer Contact
marisol santiago
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11691467
MDR Text Key252812677
Report Number0002249697-2021-00706
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 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6481-2-130
Device Catalogue Number64812130
Device Lot NumberLHS641
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 Received03/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2018
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: 04/19/2021 Patient Sequence Number: 1
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