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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #6 L-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #6 L-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5510F601
Device Problems Device Damaged Prior to Use (2284); Device Disinfection Or Sterilization Issue (2909); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 02/29/2016
Event Type  Malfunction  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Additional information has been requested. Should additional information become available it will be reported in a supplemental report upon completion of the investigation. Not returned to the manufacturer.

 
Event Description

Our distributor reported, "the package did not guarantee the sterility. ".

 
Manufacturer Narrative

An event regarding packaging damage involving a triathlon femoral 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 compressed and/or dropped from a height causing the flange of the outer blister to fracture. 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 similar events for the lot referenced. Conclusions: the investigation concluded that the packaging damage was most likely caused by excessive/incorrect handling prior to the opening packaging whereby the carton may have been compressed and/or dropped from a height causing the flange of the outer blister to fracture. No further investigation for this event is required at this time.

 
Event Description

Our distributor reported, "the package did not guarantee the sterility. ".

 
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Brand NameTRIATHLON CR FEM COMP #6 L-CEM
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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 Key5570817
MDR Text Key42984109
Report Number0002249697-2016-01194
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2020
Device Catalogue Number5510F601
Device LOT NumberABS6Y
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/12/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/26/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/12/2016 Patient Sequence Number: 1
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