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

Catalog Number 5536B400

Device Problems Malposition of Device (2616); Osseointegration Problem (3003); Positioning Problem (3009)

Patient Problems Injury (2348); Inadequate Osseointegration (2646); No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned 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.Not returned to the manufacturer.

Event Description

Total knee revision.Update as per sales rep on (b)(6) 2016, revision surgery took place as a result of tibial component malposition.

Manufacturer Narrative

An event regarding malposition involving a tritanium baseplate was reported.The event was confirmed.Method & 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: insufficient medical records were provided for review however the consulting clinician stated: there are only two post event x-rays that document the tibial baseplate is loose with gross secondary deformity and bone fracture.This secondary destruction and deformity prevent to establish an exact failure mode although the reported malposition is without doubt caused by surgical technique and as such a procedure-related failure mode because the surgeon is responsible for adequate component position.Early post implantation x-rays might reveal the kind of malposition in more detail.With the current info this is not possible although the case has clearly no device-related aspects.-device history review: device history record review was satisfactory.-complaint history review: a review of the complaint database confirmed that there were no other similar reported events for this lot id.Conclusions: insufficient medical records were provided for review however the consulting clinician stated: there are only two post event x-rays that document the tibial baseplate is loose with gross secondary deformity and bone fracture.This secondary destruction and deformity prevent to establish an exact failure mode although the reported malposition is without doubt caused by surgical technique and as such a procedure-related failure mode because the surgeon is responsible for adequate component position.Early post implantation x-rays might reveal the kind of malposition in more detail.With the current info this is not possible although the case has clearly no device-related aspects.No further investigation for this event is possible at this time as devices were not returned and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

Total knee revision.Update as per sales rep on (b)(6) 2016, revision surgery took place as a result of tibial component malposition.

• Brand Name: TRITANIUM BPLATE TRIATHLON S4
• Type of Device: PROSTHESIS, 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5720763
• MDR Text Key: 47246716
• Report Number: 0002249697-2016-01915
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 5536B400
• Device Lot Number: CTD8983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2015
• 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): Required Intervention
• Patient Age: 66 YR