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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #2 LM/RL -10MM; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #2 LM/RL -10MM; IMPLANT Back to Search Results
Catalog Number 5630-G-210
Device Problems Fitting Problem (2183); Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2015
Event Type  malfunction  
Manufacturer Narrative
When completed, the investigation results will be submitted in a supplemental report.
 
Event Description
Left medial 10mm insert unable to snap into tibial tray.Opened second insert was opened and easily went in and implanted.Dr.Suspected something odd but couldn't discern if it was his error or implant.
 
Manufacturer Narrative
An event regarding difficulty seating a triathlon pkr insert into a baseplate was reported.The event was not confirmed.Method & results: device evaluation and results: could not be performed as the subject device was not returned.Medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: all devices accepted into final stock conformed to specification.Complaint history review: there have been no similar reported events for this lot id.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
 
Event Description
Left medial 10mm insert unable to snap into tibial tray.Opened second insert was opened and easily went in and implanted.Dr.Suspected something odd but couldn't discern if it was his error or implant.
 
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Brand Name
TRIATHLON PKR INSERT X3 #2 LM/RL -10MM
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
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5038636
MDR Text Key25140861
Report Number0002249697-2015-02842
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082567
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Followup
Report Date 08/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date12/31/2017
Device Catalogue Number5630-G-210
Device Lot NumberMLT52D
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/28/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/01/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/10/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age74 YR
Patient Weight88
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