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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN FEMORAL AUGMENT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN FEMORAL AUGMENT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number UNK_JR
Device Problem Loss of Osseointegration (2408)
Patient Problems Injury (2348); Inadequate Osseointegration (2646)
Event Date 12/11/2019
Event Type  Injury  
Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
It was reported that the patient's right knee was revised.Pre-op diagnosis was for suspected loosening of the tibial baseplate.A pre-op x-ray also revealed that the bottom nub of the baseplate had become unthreaded from the baseplate.Intra- operatively, loosening of the femoral component was also noted.The patient's knee construct was revised to a ts knee with stems, cones, and augments.There are no allegations against the revised insert.The rep believes he may be able to return the explants, and will try to obtain further information.
 
Manufacturer Narrative
Additional information: update to explant date.An event regarding loosening involving an unknown femoral augment was reported.The event was not confirmed.Method & results: -device evaluation and results: the augment was returned for evaluation still attached to the femoral component.There is nothing remarkable to note.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-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, primary and revision operative reports, clinical and past medical history and additional serial dated x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
 
Event Description
It was reported that the patient's right knee was revised.Pre-op diagnosis was for suspected loosening of the tibial baseplate.A pre-op x-ray also revealed that the bottom nub of the baseplate had become unthreaded from the baseplate.Intra- operatively, loosening of the femoral component was also noted.The patient's knee construct was revised to a ts knee with stems, cones, and augments.There are no allegations against the revised insert.The rep believes he may be able to return the explants, and will try to obtain further information.
 
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Brand Name
UNKNOWN FEMORAL AUGMENT
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key9608672
MDR Text Key188648199
Report Number0002249697-2020-00145
Device Sequence Number1
Product Code MBH
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 03/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2020
Date Manufacturer Received02/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age56 YR
Patient Weight113
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