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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 Malposition of Device (2616); Positioning Problem (3009)
Patient Problem Injury (2348)
Event Date 05/15/2018
Event Type  Injury  
Manufacturer Narrative

An event regarding malposition involving a triathlon baseplate was reported. The event was confirmed through clinician review of the medical records provided. Method & results: device evaluation and results: not performed as no product was returned for evaluation. Medical records received and evaluation: the medical review indicated: baseplate malposition in excessive posterior tibial slope and excessive proximal tibial bone removal requiring implantation of a very thick 19-mm cr bearing have rendered the pcl dysfunctional with severe instability as outcome requiring revision where the problem was one partly solved by implantation of a thicker 22-mm cs bearing. Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other similar events for the lot referenced. Conclusion: the medical review indicated that baseplate malposition in excessive posterior tibial slope and excessive proximal tibial bone removal requiring implantation of a very thick 19-mm cr bearing have rendered the pcl dysfunctional with severe instability as outcome requiring revision where the problem was one partly solved by implantation of a thicker 22-mm cs bearing. No further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

Knee revision due to instability. Update based on medical review: baseplate malposition in excessive posterior tibial slope and excessive proximal tibial bone removal have rendered the pcl dysfunctional with severe instability.

 
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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 Key7805553
MDR Text Key117881888
Report Number0002249697-2018-02638
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
Type of Report Initial
Report Date 08/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2013
Device Catalogue Number5526B300
Device LOT NumberSJ66S
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/18/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/06/2008
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: 08/22/2018 Patient Sequence Number: 1
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