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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #4 LM/RL -8MM; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #4 LM/RL -8MM; IMPLANT Back to Search Results
Catalog Number 5630-G-408
Device Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/30/2015
Event Type  malfunction  
Event Description
The surgeon attempted to implant a pkr tibial insert and could not get it to lock into place.It could be removed very easily.The surgeon took it out and discovered that there could have been some cement preventing the insert to seat properly.A back up device was available.No delay.No adverse consequences.
 
Manufacturer Narrative
When completed, the investigation results will be submitted in a supplemental report.
 
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
The surgeon attempted to implant a pkr tibial insert and could not get it to lock into place.It could be removed very easily.The surgeon took it out and discovered that there could have been some cement preventing the insert to seat properly.A back up device was available.No delay.No adverse consequences.
 
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Brand Name
TRIATHLON PKR INSERT X3 #4 LM/RL -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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4719408
MDR Text Key17225623
Report Number0002249697-2015-01331
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 Other,Health Professional,health professional,oth
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/30/2015
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 Health Professional
Device Expiration Date04/30/2019
Device Catalogue Number5630-G-408
Device Lot NumberMNETP6
Other Device ID NumberSTERILE LOT# MSGNH05H5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/30/2015
Initial Date FDA Received04/22/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/21/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2014
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 Age66 YR
Patient Weight113
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