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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number TR7100-R
Device Problems Nonstandard Device (1420); Device Slipped (1584); Material Integrity Problem (2978)
Patient Problem No Code Available (3191)
Event Date 08/21/2012
Event Type  Injury  
Manufacturer Narrative
This event became a legal claim.Due to the ongoing litigation no additional information is available at this time.If additional information is received it will be reported on a supplemental report.Not returned to the manufacturer.
 
Event Description
Plaintiff underwent a total knee replacement performed with a stryker shapematch gutting guide and triathlon knee on or about (b)(6) 2012.Plaintiff alleges that the use of the shapematch cutting guide resulted in significant slope of the proximal tibia, leading to a poor outcome resulting in mechanical loosening and the need for a revision surgery.Suit filed in (b)(6).Requires revision surgery (not revised yet).
 
Manufacturer Narrative
An event regarding a sloped tibial tray involving a us shapematch cutting guide was reported.The event was not confirmed.Method & results:-device evaluation and results: device evaluation was not performed as no devices were received.-medical records received and evaluation: insufficient medical records were received for review with a clinical consultant.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock.Complaint history review: a search of the super and chs complaint databases indicates that similar events have occurred for the us shapematch cutting guides.Voluntary hold (b)(4) and voluntary recall ra 2012-171 were issued.Conclusions the exact cause of the event could not be determined because the devices were not returned for evaluation and insufficient medical information was provided.Further information such as x-ray images, recent clinical follow up and confirmation of patients complaint of dislocation are needed to complete the investigation for determining root cause.
 
Event Description
Plaintiff underwent a total knee replacement performed with a stryker shapematch gutting guide and triathlon knee on or about (b)(6) 2012.Plaintiff alleges that the use of the shapematch cutting guide resulted in significant slope of the proximal tibia, leading to a poor outcome resulting in mechanical loosening and the need for a revision surgery.Suit filed in (b)(4).Requires revision surgery (not revised yet).
 
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Brand Name
PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY
Type of Device
PROSTHESIS, 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-ALAMEDA
1600 harbor bay parkway
suite 200
alameda CA 94502
Manufacturer Contact
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5947808
MDR Text Key54626630
Report Number0002249697-2016-02929
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 08/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberTR7100-R
Device Lot Number12167034
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/14/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number2249697-11/19/12-013-R
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
Patient Weight90
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