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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #6 RM/LL -8MM; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #6 RM/LL -8MM; IMPLANT Back to Search Results
Catalog Number 5630-G-628
Device Problems Device Abrasion From Instrument Or Another Object (1387); Material Integrity Problem (2978); Positioning Problem (3009); Scratched Material (3020)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/17/2013
Event Type  malfunction  
Event Description
While doing a rt.Knee medial compartment arthroplasty using the triathlon pkr system at (b)(6), dr.Tried to implant a rt.Medial/lt.Lateral size 6 8 mm tibial bearing insert (cat #5630-g-628 lot: mlrjrk) and the implant would not lock into the baseplate adequately.The anterior/medial aspect of the bearing insert would not fully engage into the baseplate and was sitting proud and loose.After numerous attempts to reposition the implant the decision was made to remove it and put in another bearing of the same size.The second implant slid right into place, was impacted once and fully seated with minimal effort.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
An event regarding difficulty seating a triathlon pkr insert into a baseplate was reported.The event was confirmed.Method & results: -device evaluation and results: the anterior locking features were returned damaged, confirming the event.-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 investigation concluded that damage is likely caused by misaligning the insert with the baseplate during implantation.
 
Event Description
While doing a rt.Knee medial compartment arthroplasty using the triathlon pkr system at (b)(6), dr.Tried to implant a rt.Medial/lt.Lateral size 6 8 mm tibial bearing insert (cat #5630-g-628 lot: mlrjrk) and the implant would not lock into the baseplate adequately.The anterior/medial aspect of the bearing insert would not fully engage into the baseplate and was sitting proud and loose.After numerous attempts to reposition the implant the decision was made to remove it and put in another bearing of the same size.The second implant slid right into place, was impacted once and fully seated with minimal effort.
 
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Brand Name
TRIATHLON PKR INSERT X3 #6 RM/LL -8MM
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
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key3558322
MDR Text Key4077930
Report Number0002249697-2014-00071
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 Company Representative,company representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/17/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2017
Device Catalogue Number5630-G-628
Device Lot NumberMLRJRK
Other Device ID NumberSTERILE LOT MSGLR07H5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received08/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2012
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 Age53 YR
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