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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT PS#7 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT PS#7 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5532G716
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Pain (1994); Fluid Discharge (2686)
Event Date 11/18/2015
Event Type  Injury  
Manufacturer Narrative

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. Not returned to the manufacturer.

 
Event Description

Patient had a total knee done at a different facility. Complaint of pain when knee is effused. Doctor examined preoperatively and at 10 degree flexion opened up medially 20 degree. Just by inserting a 7 x 19 poly, the knee was more stable. The knee was loose before surgery, was on blood thinner due to having a heart valve transplant, so effusion came easily which caused pain. Surgeon hopes a tighter knee will decrease chance of effusions. No implants were loose and broken. Left knee.

 
Manufacturer Narrative

An event regarding revision surgery due to pain, effusion and instability involving a triathlon ps insert was reported. The event was not confirmed. Device history review: the device was manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other similar events for the lot referenced. Conclusions: revision surgery took place to pain, effusion and an unstable knee whereby a thicker insert was implanted. The exact cause of the event could not be determined because insufficient information was provided. Further information such as product return, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause. A capa trend analysis was conducted for the reported failure mode and concluded instability may result from other factors not necessarily related to the device. No further investigation is possible at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

Patient had a total knee done at a different facility. Complaint of pain when knee is effused. Dr. Examined preoperatively and at 10 degree flexion opened up medially 20 degree. Just by inserting a 7 x 19 poly, the knee was more stable. The knee was loose before surgery, was on blood thinner due to having a heart valve transplant, so effusion came easily which caused pain. Surgeon hopes a tighter knee will decrease chance of effusions. No implants were loose and broken. Left knee.

 
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Brand NameX3 TRIATHLON INSERT PS#7 16MM
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5293633
MDR Text Key33401740
Report Number0002249697-2015-04250
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/18/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/14/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2014
Device Catalogue Number5532G716
Device LOT NumberLBL712
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/08/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/14/2015 Patient Sequence Number: 1
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