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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 9MM KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 9MM KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS Back to Search Results
Catalog Number 5531G709
Device Problems Loose or Intermittent Connection (1371); Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 06/30/2015
Event Type  Injury  
Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

 
Event Description

It was reported that the surgeon revised a size 9 x 3 tibial insert on (b)(6) 2015. Poly was revised due to patient having a grossly loose knee. Surgeon revised poly with a thicker poly. Surgeon revised from a size 9 to size 16 insert. Surgeon noted patient had good range of motion and the explanted poly insert was pristine.

 
Manufacturer Narrative

An event regarding revision due to instability involving a triathlon cs insert was reported. The event was not confirmed. Method & results: device evaluation and results: visual inspection of the returned device indicates that the device appears normal for a poly component that was implanted and subsequently explanted. Medical records received and evaluation: not performed as medical records were not received for review. 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: based on the visual inspection the returned device indicates that the device appears normal for a poly component that was implanted and subsequently explanted. The surgeon explanted the 9mm thick insert component and replaced it with a 16mm to address the instability in the joint. 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 for this event is possible at this time. If additional information becomes available, this investigation will be reopened.

 
Event Description

It was reported that the surgeon revised a size 9 x 3 tibial insert on (b)(6) 2015. Poly was revised due to patient having a grossly loose knee. Surgeon revised poly with a thicker poly. Surgeon revised from a size 9 to size 16 insert. Surgeon noted patient had good range of motion and the explanted poly insert was pristine.

 
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Brand NameX3 TRIATHLON CS INSERT #7 9MM
Type of DeviceKNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
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 Key5062506
MDR Text Key25212760
Report Number0002249697-2015-02938
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 08/12/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2018
Device Catalogue Number5531G709
Device LOT NumberLDH508
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/08/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/08/2013
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: 09/08/2015 Patient Sequence Number: 1
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