MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S3; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESI

Catalog Number 5536B300

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 11/13/2015

Event Type  malfunction  

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

Per (b)(6) survey, surgeon stated, "a tibia was with an overhang at lateral posterior.".

Manufacturer Narrative

An event regarding alleged malposition (overhang at lateral posterior) involving a tritanium baseplate was reported.The event was not confirmed.Conclusions: the exact cause of the event could not be determined due to insufficient provision of information.Further information such as: return of reported devices; valid lot information; x-rays; operative reports as well as patient history and follow up notes are needed to complete the investigation to determine root cause.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

Per pms survey, surgeon stated, "a tibia was with an overhang at lateral posterior.".

• Brand Name: TRITANIUM BPLATE TRIATHLON S3
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESI
• 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: 5290667
• MDR Text Key: 33944227
• Report Number: 0002249697-2015-04200
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• 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: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5536B300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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