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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #4L KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #4L KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS Back to Search Results
Catalog Number 5517F401
Device Problems Malposition of Device (2616); Positioning Problem (3009)
Patient Problem Injury (2348)
Event Date 10/11/2017
Event Type  Injury  
Manufacturer Narrative

An event regarding malposition involving a triathlon femoral component was reported. The event was confirmed. Method and results: device evaluation and results: not performed as product remains implanted medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: excessive posterior tibial baseplate slope of 9°, relative varus position of the baseplate of 5°, excessive distal femoral bone resection with thin tibial bearing, twisting trauma as trigger event for clinical symptoms. 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: clinician review of the records provided indicated: complex and multiple component malposition as related to baseplate malposition in varus and excessive posterior slope, varus deformity across the knee and excessive distal femoral bone resection with use of a thin cr bearing has contributed to progressive knee instability where a twisting trauma to the knee was the trigger event to bring clinical symptoms to the level of medical attention with revision surgery and liner exchange performed within 2-years of implantation. No further investigation is possible at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened. Implanted.

 
Event Description

The surgeon reported via the sales rep, (b)(6) that a female patient underwent a revision of the left knee on (b)(6) 2017 due to a fractured tibial insert size 3 9 mm. It was further reported that the patient had experienced a twisting trauma to the knee approximately 2 months prior to the revision. It was further reported that the operation began as an exploratory endoscopy but was transferred to an open procedure when it was discovered that the insert had fractured. It was further reported that the insert was replaced with a size 3 11 mm insert and that the primary operation took place on (b)(6) 2016. **update: the medical review concluded malposition of both the femoral component and the baseplate.

 
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Brand NameTRIATHLON P/A CR BEADED #4L
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 Key7233630
MDR Text Key98753231
Report Number0002249697-2018-00288
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 02/01/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5517F401
Device LOT NumberANM8M
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 Received01/05/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/17/2015
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: 02/01/2018 Patient Sequence Number: 1
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