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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 Problems Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2016
Event Type  malfunction  
Manufacturer Narrative
Additional information has been requested.Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.
 
Event Description
It was reported that the surgeon observed what initially appeared her as being a scratch, but turned out to be a speck of powder on the posterior surface, near the taper junction of the implant.It was reported that she wiped it off, but said that she was not willing to implant into the patient.
 
Manufacturer Narrative
An event regarding packaging damage involving a gmrs distal femoral component was reported.The event was confirmed.Method and results: device evaluation and results: based on the visual inspection of the returned packaging it appears that this component packaging was subjected to excessive/inappropriate handling whereby the carton may have been compressed and/or dropped from a height causing relative movement of the device within the inner blister which generates white powder-like particles of the petg packaging material.This damage is as a result of excessive handling.Medical records received and evaluation: not performed as the event is related to a packaging issue and no adverse consequences to the patient were reported.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation concluded that the packaging damage was most likely caused by excessive/incorrect handling during transportation/storage.No further investigation for this event is required at this time.
 
Event Description
It was reported that the surgeon observed what initially appeared her as being a scratch, but turned out to be a speck of powder on the posterior surface, near the taper junction of the implant.It was reported that she wiped it off, but said that she was not willing to implant into the patient.
 
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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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5750465
MDR Text Key48214200
Report Number0002249697-2016-02054
Device Sequence Number1
Product Code KRO
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 company representative,other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2020
Device Catalogue Number64952010
Device Lot NumberEL8FM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received07/29/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/30/2015
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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