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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #4 L-CEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #4 L-CEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Catalog Number 5510F401
Device Problems Device Disinfection Or Sterilization Issue (2909); Difficult to Open or Remove Packaging Material (2922); Packaging Problem (3007)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 10/19/2016
Event Type  Malfunction  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

Sales rep informed following information by the phone. Nurse had called and informed that they couldn't get the item ref 5510f401 out of the box in sterile manner during the operation. There was a few minutes delay during the operation because new implant had to be taken to continue the operation.

 
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 damage to the carton and outer blister. -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 damage to the carton and outer blister. It must be noted that the event description states that item ref 5510f401 could not be removed from the box in sterile manner during the operation, this was most likely as a result of the damage to the unit carton. No further investigation for this event is required at this time.

 
Event Description

Sales rep informed following information by the phone. Nurse had called and informed that they couldn't get the item ref 5510f401 out of the box in sterile manner during the operation. There was a few minutes delay during the operation because new implant had to be taken to continue the operation.

 
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Brand NameTRIATHLON CR FEM COMP #4 L-CEM
Type of DevicePROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6104555
MDR Text Key60317118
Report Number0002249697-2016-03611
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeFI
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 01/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/15/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5510F401
Device LOT NumberBEN4S
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/26/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/26/2016
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: 11/15/2016 Patient Sequence Number: 1
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