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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 22MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 22MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5537-G-522
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Injury (2348)
Event Date 07/07/2015
Event Type  Injury  
Manufacturer Narrative

No 5. Triathlon ts plus tibial insert x3 poly 22mm; cat# 5537-g-522; lot# mkh59l. The following other devices were also listed in this report: tri ts femur sz6 right; cat# 5512-f-602; lot# fwvj. Tri ts baseplate size 5; cat# 5521-b-500; lot# jtwm. Triathlon symmetric x3 patella; cat# 5550-g-360; lot# xlpw. Tri post augment sz6 10mm; cat# 5544-a-600; lot# jasu. Triathlon femoral distal augment 10mm - size 6 right; cat# 5541-a-602; lot# itmj. Triathlon femoral distal augment 10mm - size 6 right; cat# 5541-a-602; lot# jkfm. Tri press-fit stem 25mm x 100mm; cat# 5565-s-025; lot# m5h16d. Tri press-fit stem 24mm x 100mm; cat# 5565-s-024; lot# m8t33. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. This event was reported via clinical outcomes reporting studies. An evaluation of the device cannot be performed as the device was not made available 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

On (b)(6) 2015, patient had all components revised and underwent first stage of a two stage exchange utilizing a hinged knee system.

 
Manufacturer Narrative

An event regarding infection involving a no 5. Triathlon ts plus tibial insert x3 poly 22mm was reported. The event was not confirmed. Method and results: device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation. Medical records received and evaluation: no medical records or x-rays were made available for evaluation. Device history review: review of the device history records indicates all devices accepted into final stock met specifications. Complaint history review: there have been no other events for this lot and sterile lot. Conclusions: the source of the infection could not be determined as patient information, clinical history, and results of bloodwork for infection were not provided. A capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting. No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics. If devices and/or additional information become available, this investigation will be reopened.

 
Event Description

On (b)(6) 2015, patient had all components revised and underwent first stage of a two stage exchange utilizing a hinged knee system.

 
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Brand NameNO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 22MM
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
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5316255
MDR Text Key34048843
Report Number0002249697-2015-04450
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 HEALTH PROFESSIONAL,OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2016
Device Catalogue Number5537-G-522
Device LOT NumberMKH59L
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 Received01/29/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/12/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/21/2015 Patient Sequence Number: 1
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