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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5532-G-409
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Pain (1994); Rupture (2208); Injury (2348); Arthralgia (2355); Ambulation Difficulties (2544)
Event Date 08/17/2014
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.

 
Event Description

Patient felt sudden pain in her left knee and states she felt a bump over her left knee. She had pain with range of motion and with walking. She presented with these complaints at dr. (b)(6) clinic on (b)(6) 2014. X-rays and physical exam revealed a laterally subluxated patella and mpfrl rupture. Patient underwent revision tka on (b)(6) 2014 involving a liner exchange and medial imbrication & lateral release.

 
Manufacturer Narrative

An event regarding patella subluxation and a insert exchange involving a triathlon insert component was reported. The event was not confirmed. Method & results: device evaluation and results: not performed as the device was not returned for evaluation. Medical records received and evaluation: review by a clinical consultant suggested that "there is no evidence that the patella maltracking on the left total knee arthroplasty, which responded to a soft tissue repair, was the result of factors of faulty component design, manufacturing or materials. " device history review: the device was manufactured and accepted into final stock with no reported discrepancies. Complaint history review: not performed because no product specific failure mode was reported. Conclusions: review by a clinical consultant suggested that "there is no evidence that the patella maltracking on the left total knee arthroplasty, which responded to a soft tissue repair, was the result of factors of faulty component design, manufacturing or materials. " no further investigation for this event is possible at this time. If additional information becomes available, this investigation will be reopened.

 
Event Description

Patient felt sudden pain in her left knee and states she felt a bump over her left knee. She had pain with range of motion and with walking. She presented with these complaints at dr. (b)(6) clinic on (b)(6) 2014. X-rays and physical exam revealed a laterally subluxated patella and mpfrl rupture. Patient underwent revision tka on (b)(6) 2014 involving a liner exchange and medial imbrication & lateral release.

 
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Brand NameTRIATHLON PS 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-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5275141
MDR Text Key32983163
Report Number0002249697-2015-04171
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 LITERATURE,OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/12/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2018
Device Catalogue Number5532-G-409
Device LOT NumberMMT1V9
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 Received01/06/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/16/2013
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: 12/08/2015 Patient Sequence Number: 1
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