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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5520B500
Device Problems Break (1069); Device Damaged Prior to Use (2284); Device Disinfection Or Sterilization Issue (2909); Device Packaging Compromised (2916); Packaging Problem (3007)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2016
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was noticed upon opening the outer box of a size 5 triathalon primary tibial baseplate, the inner plastic seal to the implant had been broken and the implant was not sterile. Rep informed the dr. And supplied him with a back up implant of the same size and description.
 
Manufacturer Narrative
Corrected data: an event regarding packaging damage involving a triathlon baseplate was reported. The event was confirmed. Method & results: device evaluation and results: one photograph was received. The photograph shows the outer blister with one side flange broken away from the outer blister. The broken side flange remains attached to the tyvek paper. Medical records received and evaluation: not performed as the event relates to a packaging issue. Device history review: indicated devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: chr review determined that there were no similar events reported for the lot. Conclusions: the exact cause of the event could not be determined because insufficient information was received. Further information such as all packaging is required to complete the investigation for determining root cause. No further investigation for this event is possible at this time. If packaging becomes available, this investigation will be reopened. Not returned.
 
Event Description
It was noticed upon opening the outer box of a size 5 triathalon primary tibial baseplate, the inner plastic seal to the implant had been broken and the implant was not sterile. Rep informed the dr. And supplied him with a back up implant of the same size and description.
 
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Brand NameTRIATHLON PRIM CEM FXD BPLT #5
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 Key6235700
MDR Text Key64614032
Report Number0002249697-2017-00147
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Catalogue Number5520B500
Device Lot NumberBJH2P
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2016
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: 01/09/2017 Patient Sequence Number: 1
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