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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT Back to Search Results
Catalog Number UNK_REC
Device Problems Break (1069); Loose or Intermittent Connection (1371); Material Separation (1562); Metal Shedding Debris (1804)
Patient Problem Pain (1994)
Event Date 04/17/2014
Event Type  Injury  
Event Description
It was reported that the patient came to surgeon with knee pain.X-ray shows potential loosening on both femur and tibia.Upon incision on this revision the tissues were black from metal debris.When removing the tibia, the stem had separated from the baseplate.This is what is surmised as being the reason for the debris due to constant shifting of the tibia, broke the threads of the stem to tibia and rubbed.This was told as conjecture by surgeon during case.Complete debridement was done.Revision with a depuy revision knee was successfully done by surgeon.
 
Manufacturer Narrative
Catalog number is unknown at this time.Device description reported as unknown femoral component.Additionally, an unknown femoral augment was reported.Based on the minimal information received, it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
 
Manufacturer Narrative
The patient is (b)(6) in height.An event regarding loosening involving an unknown femoral component was reported.The event was confirmed.Method and results: device evaluation and results: the internal surface of the femoral component still has bone cement attached, in particular distally and around the stabiliser box.There is some evidence of bone interdigitation.The external bearing surface shows a/p wear tracks on both condyles consistent with clinical use and some explantation damage medical records received and evaluation: x-rays confirm bone loss behind both femoral and tibial component with a reported non-displaced femoral condylar fracture.Root failure mechanism relates to the use of cemented fixation for the tibial stem extender which lead to uncoupling from the baseplate when the baseplate became loose because of the continuous rotatory movements during gait creating an overload on the connection between stem extender and baseplate connector between loose and well-fixed section of the device construct.No arguments for either device-related or patient-related factors and as such root cause of failure with regard to uncoupling of the device with all its secondary effects of metal debris generation is procedure-related and not device-related as also supported by the mar findings.Conclusions: the investigation concluded that the femoral loosening was caused by bone loss behind the femoral component with a non-displaced femoral condylar fracture.The tibial loosening was caused by the use of cemented fixation for the tibial stem extender which lead to uncoupling from the baseplate when the baseplate became loose because of the continuous rotatory movements during gait creating an overload on the connection between stem extender and baseplate connector between loose and well-fixed section of the device construct.The root cause of failure with regard to uncoupling of the device with all its secondary effects of metal debris generation is procedure-related and not device-related as also supported by the mar findings.
 
Event Description
It was reported that the patient came to surgeon with knee pain.X-ray shows potential loosening on both femur and tibia.Upon incision on this revision the tissues were black from metal debris.When removing the tibia, the stem had separated from the baseplate.This is what is surmised as being the reason for the debris due to constant shifting of the tibia, broke the threads of the stem to tibia and rubbed.This was told as conjecture by surgeon during case.Complete debridement was done.Revision with a depuy revision knee was successfully done by surgeon.
 
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Brand Name
UNKNOWN_RECONSTRUCTIVE_PRODUCT
Type of Device
IMPLANT
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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4221921
MDR Text Key5074230
Report Number0002249697-2014-04166
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_REC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/04/2014
Initial Date FDA Received11/03/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/04/2014
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) Required Intervention;
Patient Age74 YR
Patient Weight92
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