MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS,

Catalog Number 5536B400

Device Problems Fracture (1260); Loss of Osseointegration (2408); Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); Injury (2348); Inadequate Osseointegration (2646)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Informed about a planned revision of a triathlon tritanium base plate.

Manufacturer Narrative

An event regarding malposition of the tritanium baseplate was reported.The event was confirmed through x-rays provided.Method & results: -device evaluation and results: the femoral, baseplate, and insert component were returned for evaluation.The baseplate had one of the fixation pegs broken/cut off.There is significant damage anteriorly to the underside of the baseplate as well as laterally and posteriorly.All this type of damage is most likely caused by a cutting tool during explantation.There is also bone ingrowth visible on the underside of the baseplate, most noticable on the anterior surface.-medical records received and evaluation: baseplate malposition is the principal problem of this knee contributing to overload with progressive instability and impending loosening of the baseplate within a year of implantation.A principal and major contributor to the present knee instability was the excessive posterior tibial slope of the baseplate with an angle of 16°.Under normal implantation conditions, this should never be more than 5°, usually between 0° - 5°.No device-related factors are evident from the material as also supported by the findings on the explanted devices, neither would this be required to understand the failure mechanism that is completely explained by procedure-related factors concerning the type and malposition of the devices which is under the full responsibility of the surgeon.This case is not device-related.-device history review: the device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: review of the medical records provided indicated that baseplate malposition is the principal problem of this knee contributing to overload with progressive instability and impending loosening of the baseplate within a year of implantation.There is no information about the revision surgery performed, but the fact that the well fixed femoral component was also removed indicates that at least ps or ts types of components were implanted.Because optimal component choice and position are the responsibility of the surgeon, root cause of failure is procedure-related factors (cr component choice, baseplate malposition).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

Informed about a planned revision of a triathlon tritanium base plate.

• Brand Name: TRITANIUM BPLATE TRIATHLON S4
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS,
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6404185
• MDR Text Key: 69921446
• Report Number: 0002249697-2017-00901
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041491
• UDI-Public: (01)07613327041491(11)150930(17)200930(10)CTD8174
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 5536B400
• Device Lot Number: CTD8174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 79