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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5530-G-311
Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 10/30/2016
Event Type  Injury  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

Patient had a triathlon knee (b)(6) 2010 and when reviewed in (b)(6) 2015 complained of pain. Patient underwent revision left knee surgery and the 11mm cr insert was removed and replaced with a 16 mm cs insert.

 
Manufacturer Narrative

Reported event: an event regarding wear involving a triathlon insert was reported. The event was confirmed. Method & results: -device evaluation and results: a visual inspection of the returned device noted wear impression markings on the distal surface of the insert, consistent with contact against the baseplate. Explantation damage was observed on the anterior surface of the insert. Damage was also observed on the posterior surface of the insert. Delamination, burnishing, scratching, third-body indentations and embedded debris was also observed on the condyles. A material analysis was conducted on the received devices and the report concluded "delamination, burnishing, scratching, pitting and third-body indentations were observed on the condyles. These are common damage modes of uhmwpe. Wear impression markings, explantation damages and embedded debris were also observed on the insert. No material or manufacturing defects were observed on the surfaces examined. " -medical records received and evaluation: not performed as no medical records were provided. -device history review: indicated the devices accepted into final stock from the reported lot were free from discrepancies. -complaint history review: there has been no other event for the lot referenced. Conclusions: a material analysis was conducted on the received devices and the report concluded "delamination, burnishing, scratching, pitting and third-body indentations were observed on the condyles. These are common damage modes of uhmwpe. Wear impression markings, explantation damages and embedded debris were also observed on the insert. No material or manufacturing defects were observed on the surfaces examined. " the event was confirmed but the root cause could not be determined. No further investigation for this event is possible at this time. If the additional information will be received, this investigation will be reopened and re-evaluated.

 
Event Description

Patient had a triathlon knee (b)(6) 2010 and when reviewed in (b)(6) 2015 complained of pain. Patient underwent revision left knee surgery and the 11mm cr insert was removed and replaced with a 16mm cs insert.

 
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Brand NameTRIATHLON CR X3 TIBIAL INSERT
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
jadwiga degrado
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6118603
MDR Text Key60580402
Report Number0002249697-2016-03745
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAU
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 01/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2014
Device Catalogue Number5530-G-311
Device LOT NumberMHL3X6
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/23/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/08/2009
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: 11/21/2016 Patient Sequence Number: 1
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