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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_KNEE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_KNEE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number UNK_JR
Device Problem Unintended Movement (3026)
Patient Problem Pain (1994)
Event Date 02/29/2024
Event Type  Injury  
Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
 
Event Description
It was reported through stryker facebook page: i had my knee replacement last (b)(6) 2023 and have nothing but pain everyday.I feel like a cripple.Had another ortho dr look at it and was told the plastic in between the metal is too thin and my knee is shifting causing "slight opening to varus stress mid flexion."the option i was given is a revision surgery with no guarantee this will help me.The reason i chose a robotic assisted surgery was to be assured the size and placement would be accurate.I reached out to stryker and did not get a return call.Additional facebook comment received, "my mako surgery did not go well.The plastic part in my knee joint is too thin and my knee is shifting and i've been in pain for almost 11 months now.".
 
Event Description
It was reported through stryker facebook page: i had my knee replacement last (b)(6) 2023 and have nothing but pain everyday.I feel like a cripple.Had another ortho dr look at it and was told the plastic in between the metal is too thin and my knee is shifting causing "slight opening to varus stress mid flexion."the option i was given is a revision surgery with no guarantee this will help me.The reason i chose a robotic assisted surgery was to be assured the size and placement would be accurate.I reached out to stryker and did not get a return call.Additional facebook comment received, "my mako surgery did not go well.The plastic part in my knee joint is too thin and my knee is shifting and i've been in pain for almost 11 months now." additional fb comment received , "i just learned that the stryker knee that i have has the wrong size plastic part and it's causing my knee to shift and giving me continual pain.".
 
Manufacturer Narrative
An event regarding subsidence involving an unknown knee component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product remains implanted.Clinician review:no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, xrays 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 reopened.
 
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Brand Name
UNKNOWN_KNEE
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
arunabha mukherjee
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key18985939
MDR Text Key338696740
Report Number0002249697-2024-00503
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_JR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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