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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; IMPLANT Back to Search Results
Catalog Number 5532-G-511
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2015
Event Type  malfunction  
Event Description
Surgeon was doing a total knee on patient and when surgeon asked for the insert to be opened, immediately upon opening the inner packaging the insert was noticed to be a different type and size than what was listed on the outer box.Box stated part as p# 5532-g-511 lot ld807y and implant inside box was p#5537-g-319 lot tt6jt2.
 
Manufacturer Narrative
When completed, the investigation results will be submitted in a supplemental report.
 
Manufacturer Narrative
Device history review: review of the device history records indicate devices were manufactured and accepted into final stock complaint history review: there has been (b)(4) other event for this lot.Nc pr was previously raised for the same product and issue.A full complaint investigation was conducted and documented under pr and determined the product mix occurred due to a router swap.Nc was raised to investigate and address the confirmed product mix and router swap.
 
Event Description
Surgeon was doing a total knee on patient and when surgeon asked for the insert to be opened, immediately upon opening the inner packaging the insert was noticed to be a different type and size than what was listed on the outer box.Box stated part as p# 5532-g-511 lot ld807y and implant inside box was p#5537-g-319 lot tt6jt2.
 
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Brand Name
TRIATHLON PS X3 TIBIAL INSERT
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4853701
MDR Text Key19302335
Report Number0002249697-2015-01973
Device Sequence Number1
Product Code MBH
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 Other,Health Professional,health professional,oth
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 05/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2020
Device Catalogue Number5532-G-511
Device Lot NumberLD8D7Y
Other Device ID NumberSTERILE LOT# MSGPH30A6
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/28/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number2249697-6/10/2015-007R
Patient Sequence Number1
Patient Outcome(s) Other;
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