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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 -8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #2 LM/RL -8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 5630-G-208
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Neuropathy (1983); Injury (2348)
Event Date 10/15/2014
Event Type  Injury  
Event Description
My mother received a partial knee replacement in (b)(6) 2014.Knee became infected which resulted in a second surgery in (b)(6) 2015 to clear out infected area.Was put on 6 weeks of iv antibiotics and subsequently developed clostridium difficile (c.Difficile) and neuropathy in both legs.She has been significantly, and most probably permanently, compromised as a result of this infection.
 
Manufacturer Narrative
Catalogue number unknown at this time.Device description reported as an unknown stryker knee.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
 
Manufacturer Narrative
The following other devices were added in this report: triathlon pkr baseplate #2 lm/rl; cat# 5620-b-201; lot# gvap.Triathlon pkr femur #2 lm/rl; cat# 5610-f-201; lot# jfuy.Simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mev041.An event regarding an alleged infection involving a triathlon insert was reported.The event was not confirmed.Conclusions: device evaluation and results: not performed as no device was returned.Medical records received and evaluation: the provided medical information was reviewed by a consulting clinician who concluded: "there is no evidence this periprosthetic infection was related to factors of faulty unicompartmental component design, manufacturing or materials." device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: there have been no other events for this lot or sterile lot indicated.Conclusions: patient had tested positive for sedimentation rate and c-reactive protein levels elevating, however the source of the infection could not be determined as no examination of the explanted component and no follow-up subsequent to the (b)(6) 2015 visit referable to her knee were available.A capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.
 
Event Description
My mother received a partial knee replacement in (b)(6) 2014.Knee became infected which resulted in a second surgery in (b)(6) 2015 to clear out infected area.Was put on 6 weeks of iv antibiotics and subsequently developed clostridium difficile (c.Difficile) and neuropathy in both legs.She has been significantly, and most probably permanently, compromised as a result of this infection.
 
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Brand Name
TRIATHLON PKR INSERT X3 #2 LM/RL -8MM
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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 colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4908634
MDR Text Key6025458
Report Number0002249697-2015-02303
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,Consumer,consumer,other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date06/30/2018
Device Catalogue Number5630-G-208
Device Lot NumberMMJPML
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/17/2015
Initial Date FDA Received07/13/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2013
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) Required Intervention;
Patient Age81 YR
Patient Weight59
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