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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 20MM XS/S S1/S2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 20MM XS/S S1/S2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 6481-3-220
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994)
Event Date 08/03/2021
Event Type  Injury  
Manufacturer Narrative
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. 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. The following devices were also listed in this report: mrhk tibial sleeve; cat#64812140; lot#lkl786 ,mrh tib rot comp xs-xl; cat#64812100; lot#167626a ,mrhk bumper insert 3 degrees; cat#64812133;lot#lkp578 ,mrh axle; cat# 64812120ctd;lot#54907 ,mrhk femoral bushing; cat#64812110;lot#lkl435 ,mrhk femoral bushing; cat#64812110;lot#lkm029 ,mrh knee fem xs rht; cat#64811101; lot#jsl3b ,mrh tibial b/plt keel sml 1; cat#64813110; lot#lxr9s ,triathlonctrfemconeaug sz3&4r; cat#5549-a-642; lot#k1ej ,triathlon sym cone aug sz b; cat#5549-a-120; lot#p9pp1 ,tri press-fit stem 16mm x 100mm; cat#5565-s-016; lot#0081917a ,tri press-fit stem 10mm x 100mm; cat#5565-s-010; lot#0083056e ,mrhk fem distal blk 10mm xs; cat#64811200; lot#jba2d ,mrhk fem distal blk 10mm xs; cat#64811200; lot#j9x9a ,and it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
 
Event Description
Patient underwent right index tka outside cors scope. On (b)(6) 2021 patient presents with pain and is studied for infection. She is revised for pji on (b)(6) 2021. Liner and all rotating components were exchanged.
 
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Brand NameMRHK TIB INS 20MM XS/S S1/S2
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
arokiya raj
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13732803
MDR Text Key287015812
Report Number0002249697-2022-00375
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994207
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 03/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6481-3-220
Device Catalogue Number64813220
Device Lot NumberLKH227
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2020
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: 03/11/2022 Patient Sequence Number: 1
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