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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A PS BEADED #6L PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A PS BEADED #6L PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5516F601
Device Problems Crack (1135); Device Packaging Compromised (2916); Torn Material (3024); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2016
Event Type  Malfunction  
Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

 
Event Description

Primary knee case. Rep pulled implant from cart and opened the outer box, which was intact. Upon opening the box and pulling out implant, it was found that the first layer of sterile packaging was cracked and was torn. No damage to the inner most layer or implant. Implant was not used, back up was available to complete surgery.

 
Manufacturer Narrative

The device was not returned for evaluation. An event regarding packaging damage involving a triathlon femoral component was reported. The event was not confirmed. Method & results: device evaluation and results: not performed as product was not returned. 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: it was reported that the first layer of sterile packaging was cracked and torn. The exact cause of the event could not be determined because insufficient information was provided. Further information such as photographs/product return are needed to complete the investigation for determining a root cause. No further investigation is possible at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened. Not returned to the manufacturer.

 
Event Description

Primary knee case. Rep pulled implant from cart and opened the outer box, which was intact. Upon opening the box and pulling out implant, it was found that the first layer of sterile packaging was cracked and was torn. No damage to the inner most layer or implant. Implant was not used, back up was available to complete surgery.

 
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Brand NameTRIATHLON P/A PS BEADED #6L
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 Key5548761
MDR Text Key42345039
Report Number0002249697-2016-01094
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/11/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/05/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5516F601
Device LOT NumberAN94K1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/02/2015
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: 04/05/2016 Patient Sequence Number: 1
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