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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HMRS DISTAL FEMUR RIGHT 12OMM; KNEE IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH HMRS DISTAL FEMUR RIGHT 12OMM; KNEE IMPLANT Back to Search Results
Catalog Number 63671112
Device Problem Degraded (1153)
Patient Problem Injury (2348)
Event Date 04/08/2019
Event Type  Injury  
Manufacturer Narrative
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.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
At (b)(6) 2008, hmrs placement of knee was performed by tumor resection.About 10 years after the surgery, the clip was pop out naturally from hmrs axis pin and pin was protruded from the femur component.Therefore, the revision surgery was done and the groove in which the clip fits was worn and could not fix the clip.Therefore, femur component, pin, clip and other attached parts were changed the new same devices.Dr 's request to check the wear of the clip groove in the femoral component.
 
Event Description
At (b)(6) 2008, hmrs placement of knee was performed by tumor resection.About 10 years after the surgery, the clip was pop out naturally from hmrs axis pin and pin was protruded from the femur component.Therefore, the revision surgery was done and the groove in which the clip fits was worn and could not fix the clip.Therefore, femur component, pin, clip and other attached parts were changed the new same devices.Dr 's request to check the wear of the clip groove in the femoral component.
 
Manufacturer Narrative
Additional information: lot code, expiration, and manufacturing date.An event regarding wear (resulting in disassociation) involving a hmrs femoral component 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.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: as reported the femoral component groove was worn, the clip was pop out naturally from hmrs axis pin and pin was protruded from the femur component.No information was available to confirm this event.Surgeon requested to check the wear of the clip groove in the femoral component but this could not be performed as the device was not returned.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post- operative x-rays and the 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.
 
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Brand Name
HMRS DISTAL FEMUR RIGHT 12OMM
Type of Device
KNEE IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8583621
MDR Text Key144179987
Report Number0002249697-2019-01857
Device Sequence Number1
Product Code NPJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 06/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2013
Device Catalogue Number63671112
Device Lot NumberSFFEF1
Was Device Available for Evaluation? No
Date Manufacturer Received05/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age66 YR
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