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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE3 BP KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE3 BP KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS Back to Search Results
Catalog Number 5526B300
Device Problems Mechanical Problem (1384); Malposition of Device (2616); Mechanical Jam (2983); Positioning Problem (3009)
Patient Problem Injury (2348)
Event Date 02/02/2017
Event Type  Injury  
Manufacturer Narrative

An event regarding a revision surgery due to instability was reported. Malposition of the triathlon baseplate was confirmed by medical records. Method & results: device evaluation and results: not performed as the product was not returned. Medical records received and evaluation: medical review of the x-rays provided concluded a principal and major contributor to the present knee instability was the excessive posterior tibial slope of the baseplate with an angle of 12°. Under normal implantation conditions, this should never be more than 5°, usually between 0° - 5°. Because optimal component choice and positioning are the responsibility of the surgeon, root cause of failure is an adverse mix of procedure-related factors (baseplate malposition) and patient-related factors (the traumatic fall). Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification. Complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot. Conclusions: baseplate malposition in excessive posterior slope (12°) caused weakening of the pcl after arthroplasty where final rupture of the pcl remains occurred after a traumatic fall of the patient, to be considered as secondary trigger event. 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 revision surgery of the knee due to instability. Reported wear of the insert. The insert was changed from a 11 mm to a 16 mm plastic.

 
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Brand NameTRIATHLON PRIM BEAD PA SZE3 BP
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 colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6578442
MDR Text Key75546298
Report Number0002249697-2017-01584
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeSE
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial
Report Date 05/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/19/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/24/2017
Device Catalogue Number5526B300
Device LOT NumberS9JJF
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 Received04/21/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/24/2012
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: 05/19/2017 Patient Sequence Number: 1
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