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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #7 L-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #7 L-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5510F701
Device Problems Break (1069); Shipping Damage or Problem (1570); Device Packaging Compromised (2916); 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 04/25/2016
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

The nurse informed the sales rep that while she was opening the package, she noticed that the plastic edge of the outer package was broken even though the paper lid was sealed. Customer implanted another product. Operation time got longer about 15 minutes.

 
Manufacturer Narrative

Reported event: 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. Product surveillance will continue to monitor for trends.

 
Event Description

The nurse informed the sales rep that while she was opening the package, she noticed that the plastic edge of the outer package was broken even though the paper lid was sealed. Customer implanted another product. Operation time got longer about 15 minutes.

 
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Brand NameTRIATHLON CR FEM COMP #7 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
sandra spokane
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5669448
MDR Text Key45589564
Report Number0002249697-2016-01665
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 NURSING ASSISTANT
Type of Report Initial,Followup
Report Date 04/25/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5510F701
Device LOT NumberASM7D
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/03/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/07/2015
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: 05/20/2016 Patient Sequence Number: 1
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