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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5531G416
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Death (1802); Bone Fracture(s) (1870); Unspecified Infection (1930); Sepsis (2067); Ventricular Tachycardia (2132); Injury (2348)
Event Date 11/25/2014
Event Type  Death  
Manufacturer Narrative

The following other devices were also listed in this report: antibiotic simplex p bone cement; cat# unknown; lot# unknown. Triathlon universal tibial baseplate; cat# unknown; lot# unknown. Triathlon tibial augment half block; cat# unknown; lot# unknown. Triathlon offset adapter; cat# unknown; lot# unknown. Triathlon fluted stem; cat# unknown; lot# unknown. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. The information in this report was provided by stryker orthopaedics legal affairs department. No additional information is available at this time. The device is not available due to the ongoing litigation. Should device or additional information become available, the evaluation summary will be submitted in a supplemental report. Not returned to the manufacturer.

 
Event Description

On (b)(6) 2014, the patient was returned to the operating room for "left knee removal of infected hardware and irrigation and debridement. However, she had a series of ventricular tachycardia episodes on the operative table and the procedure was cancelled. She died on (b)(6) 2014. ".

 
Manufacturer Narrative

Updated device information reported previously as unknown in the initial emdr associated with this pi. Simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mcv022. Tri ts baseplate size 4; cat# 5521-b-400; lot# ktzpd. Tri rm/ll tib aug sz4 10mm; cat# 5546-a-402; lot# mc7c08. Triathlon total knee system offset adapter 2mm; cat# 5570-s-020; lot# m9l44d. Tri press-fit stem 12x150mm; cat# 5566-s-012; lot# m9c49j. Reported event: an event regarding infection involving an x3 triathlon cs ins size 4 16mm was reported. The event was confirmed. Method & results: device evaluation and results: visual, dimensional, and functional inspection were not performed as the item was not returned. Medical records received and evaluation: ¿no x-rays available for review. There is no examination of the explanted components, which were apparently intact and removed for subsiding into the host tibia, which was likely osteoporotic in this obese woman with multiple medical conditions contributing to osteoporosis. The presence of osteoporosis was further suggested by the development of an intraoperative femoral fracture while preparing the femur at the primary surgery. In retrospect it would have been prudent to use a stemmed tibial component at the primary surgery due to the patient's obesity and bone stock. As a result of revision surgery seventeen days post-op the risk of infection was heightened and, in fact, occurred. Attempts to address the infection with less than a two-stage approach resulted in persistent sepsis and patellar tendon rupture. The unfortunate clinical course of subsidence of the primary tibial component and subsequent infection was not related to factors of faulty component design, manufacturing or materials of either the primary or revision total knee components. ¿ device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other events for this lot. Conclusions: the root cause could not be determined because the devices were not returned for evaluation. The clinician concluded, ¿the unfortunate clinical course of subsidence of the primary tibial component and subsequent infection was not related to factors of faulty component design, manufacturing or materials of either the primary or revision total knee components. ¿ 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) 2014, the patient was returned to the or for " left knee removal of infected hardware and irrigation and debridement. However, she had a series of ventricular tachycardia episodes on the operative table and the procedure was cancelled. She died on (b)(6) 2014. ".

 
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Brand NameX3 TRIATHLON CS INS SIZE4 16MM
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-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
jadwiga degrado
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5293618
MDR Text Key33403183
Report Number0002249697-2015-04231
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 CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/14/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2019
Device Catalogue Number5531G416
Device LOT NumberLDX564
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/13/2014
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: 12/14/2015 Patient Sequence Number: 1
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