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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS SMALL FEMORAL BUSHING; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STRYKER ORTHOPAEDICS-MAHWAH GMRS SMALL FEMORAL BUSHING; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 6495-2-105
Device Problem Degraded (1153)
Patient Problems Ambulation Difficulties (2544); Insufficient Information (4580)
Event Date 07/18/2022
Event Type  Injury  
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
It was reported that the surgeon revised the axle bushings and bumper as a result of excessive wear.
 
Manufacturer Narrative
Reported event: an event regarding wear involving a gmrs bushing was reported.The event was confirmed via evaluation of the returned device.Method & results: device evaluation and results: the device was returned for evaluation.Blood and yellow discoloration is visible on the device.The damage present on the polyethylene devices appears consistent with delamination and material loss.The damage to the bushings and bumper is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed is consistent with the absorption of synovial fluid by the device.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to pi including the product inquiry summary, and an ap and lateral view x-rays of a dmrs tka.The event description from the product inquiries summary states: it was reported that the surgeon revised the axle bushings and bumper as a result of excessive wear.The ap and lateral x-rays show a cemented gmrs tka in good position without evidence of mechanical complication.The limited documentation does not provide confirming evidence of a mechanical complication i.E., wear of the bushings and axle.As such the root cause for this cannot be determined.Should additional information become available i would be happy to further this assessment.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: an event regarding wear was reported.The device was returned for evaluation.Blood and yellow discoloration is visible on the device.The damage present on the polyethylene devices appears consistent with delamination and material loss.The damage to the bushings and bumper is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed is consistent with the absorption of synovial fluid by the device.A review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to pi including the product inquiry summary, and an ap and lateral view x-rays of a dmrs tka.The event description from the product inquiries summary states: it was reported that the surgeon revised the axle bushings and bumper as a result of excessive wear.The ap and lateral x-rays show a cemented gmrs tka in good position without evidence of mechanical complication.The limited documentation does not provide confirming evidence of a mechanical complication i.E., wear of the bushings and axle.As such the root cause for this cannot be determined.Should additional information become available i would be happy to further this assessment.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
It was reported that the surgeon revised the axle bushings and bumper as a result of excessive wear.
 
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Brand Name
GMRS SMALL FEMORAL BUSHING
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
marisol santiago
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key15188341
MDR Text Key297488577
Report Number0002249697-2022-01153
Device Sequence Number1
Product Code KRO
UDI-Device Identifier07613327048841
UDI-Public07613327048841
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K023087
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/07/2022
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 Model Number6495-2-105
Device Catalogue Number64952105
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/18/2022
Initial Date FDA Received08/08/2022
Supplement Dates Manufacturer Received10/13/2022
Supplement Dates FDA Received11/07/2022
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) Required Intervention; Hospitalization;
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