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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS DIST FEM COMP SML L 65MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STRYKER ORTHOPAEDICS-MAHWAH GMRS DIST FEM COMP SML L 65MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 64952010
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/14/2018
Event Type  malfunction  
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 events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Primary procedure, left femur.It was reported that in opening the implant, a fine white powder was witnessed on the implant.Due to sterility concerns, the implant was not used.Another implant was secured and opened while the cement was setting, with no surgical delay.
 
Manufacturer Narrative
Device evaluated by mfg.An event regarding white powder on implant upon opening the packaging (foreign matter) for a gmrs distal femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: some photographs of the device were provided by the sales rep; there is what appears to be a white powder on the edge of the taper opening on the distal femoral component.The product/pack was returned by the customer.The unit carton containing the distal femoral component (loose in the box), the ifu booklet and the patient labels were returned for evaluation.The returned device appears unremarkable; there is no evidence of the white powder as depicted in the photograph provided.Medical records received and evaluation: not performed as no medical records were provided for medical review.Device history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: some photographs of the device were provided by the sales rep; there is what appears to be a white powder on the edge of the taper opening on the distal femoral component.The product/pack was returned by the customer.The unit carton containing the distal femoral component (loose in the box), the ifu booklet and the patient labels were returned for evaluation.The returned device appears unremarkable; there is no evidence of the white powder as depicted in the photographs provided.Further information such as analysis and identification of the foreign matter, and the return of all packaging components is required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
Primary procedure, left femur.It was reported that in opening the implant, a fine white powder was witnessed on the implant.Due to sterility concerns, the implant was not used.Another implant was secured and opened while the cement was setting, with no surgical delay.
 
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Brand Name
GMRS DIST FEM COMP SML L 65MM
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
Manufacturer Contact
merin grace
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7502468
MDR Text Key107973985
Report Number0002249697-2018-01393
Device Sequence Number1
Product Code KRO
UDI-Device Identifier07613327048797
UDI-Public07613327048797
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K023087
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2022
Device Catalogue Number64952010
Device Lot NumberB9Y9B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2017
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) Other;
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