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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS PROXIMAL TIB SML; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STRYKER ORTHOPAEDICS-MAHWAH GMRS PROXIMAL TIB SML; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 64953101
Device Problems Crack (1135); Device Damaged Prior to Use (2284); Device Packaging Compromised (2916); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2016
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 outer wrapper on the outside of the box was intact with no damage.Upon opening the box, the seal was intact on the outer blister but the inner packaging on the gmrs proximal tibial implant was cracked.The component was used in the surgery, but packaging will be returned.Hospital did a sterilizing process, swabbed for culture test and used the component.
 
Manufacturer Narrative
An event regarding packaging damage involving a gmrs proximal tibial component was reported.The event was confirmed.Method & 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 dropped from a height causing two of the flanges of the outer blister to fracture.Medical records received and evaluation: not performed as the event is related to a packaging issue.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 similar events for the lot referenced.Conclusions: the investigation concluded that the packaging damage was most likely caused by excessive/incorrect handling prior to opening of the packaging.It must be noted that the device was sterilized and implanted in the patient which is considered off-label use.No further investigation for this event is required at this time.
 
Event Description
It was reported that the outer wrapper on the outside of the box was intact with no damage.Upon opening the box, the seal was intact on the outer blister but the inner packaging on the gmrs proximal tibial implant was cracked.The component was used in the surgery, but packaging will be returned.Hospital did a sterilizing process, swabbed for culture test and used the component.
 
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Brand Name
GMRS PROXIMAL TIB SML
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 Key5499054
MDR Text Key40547769
Report Number0002249697-2016-00802
Device Sequence Number1
Product Code KRO
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 02/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2019
Device Catalogue Number64953101
Device Lot Number043876B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2014
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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