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 Positioning Problem (3009); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.

Event Description

Per sales rep, surgeon believes implant sits a few millimeters posterior to where the tibial template was pinned and punched.A few millimeters of bone was present anterior to the implant after impaction.The bone was not visable when the tibial template was pinned in place.The tibial template was flushed with anterior cortical bone.

Manufacturer Narrative

An event regarding malposition of the tritanium baseplate was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as no items were returned; they remain implanted.-medical records received and evaluation:not performed as no medical records were provided.-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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.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

Per sales rep, surgeon believes implant sits a few millimeters posterior to where the tibial template was pinned and punched.A few millimeters of bone was present anterior to the implant after impaction.The bone was not visable when the tibial template was pinned in place.The tibial template was flushed with anterior cortical bone.

• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6103153
• MDR Text Key: 60311445
• Report Number: 0002249697-2016-03601
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 5536B400
• Device Lot Number: CTD11608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2016
• 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): Other
• Patient Age: 80 YR
• Patient Weight: 80