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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HMRS BEARING - 18 X 24; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STRYKER ORTHOPAEDICS-MAHWAH HMRS BEARING - 18 X 24; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 6465-6-018
Device Problems Degraded (1153); Unstable (1667); Naturally Worn (2988)
Patient Problems Ambulation Difficulties (2544); Hyperextension (4523); Joint Laxity (4526)
Event Date 03/18/2022
Event Type  Injury  
Event Description
The following was reported: revision (hmrs parts replacement).After 23 years, the poly is worn out.It is manifested by hyperextension of the knee joint and marked instability.The distal femur shows signs of wear, which shows up as metallosis in the knee joint."now after the revision surgery everything was fine again.".
 
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.
 
Event Description
The following was reported: revision (hmrs parts replacement).After 23 years, the poly is worn out.It is manifested by hyperextension of the knee joint and marked instability.The distal femur shows signs of wear, which shows up as metallosis in the knee joint."now after the revision surgery everything was fine again.".
 
Manufacturer Narrative
Reported event: an event regarding wear and instability involving a hmrs bushing was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that some scratch marks are present on the outer surface of the bushing consistent with attempted explantation.Dimensional inspection: dimensional inspection was not performed because the device was returned damaged.Functional inspection: functional inspection was not performed because the device was returned damaged.Material analysis: there is no indication that the event was a result of a material integrity issue.If further information becomes available additional testing will be performed.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to wear of the components.Visual inspection: visual inspection of the returned device indicated that some scratch marks are present on the outer surface of the bushing.There is no indication that the event was a result of a material integrity issue.If further information becomes available additional testing will be performed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary/revision operative reports 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
HMRS BEARING - 18 X 24
Type of Device
PROSTHESIS, 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
anna ryan
raheen business park
limerick NA
EI   NA
61498200
MDR Report Key14073858
MDR Text Key288994391
Report Number0002249697-2022-00510
Device Sequence Number1
Product Code KRO
UDI-Device Identifier07613327048216
UDI-Public07613327048216
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K122015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number6465-6-018
Device Catalogue Number64656018
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/12/2022
Was Device Evaluated by Manufacturer? Yes
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;
Patient SexFemale
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