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

Catalog Number 5536B400

Device Problem Migration (4003)

Patient Problems Pain (1994); Injury (2348)

Event Date 09/23/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding subsidence involving a tritanium baseplate was reported; the event was not confirmed.Method & results: device evaluation and results: not performed as no product was returned for evaluation.Medical records received and evaluation: a review of the provided x-rays by a clinical consultant was rejected stating "need operative reports, need patient histopathology reports, serial x-rays, office/clinical notes and examination of the explanted components." device history review: not performed as lot details are unknown.Complaint history review: not performed as lot details are unknown.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op xrays, patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

It was reported that patient's right knee was revised.As reported by rep: "the surgeon states the tritanium tibia appears to have subsided.Patient has tibial knee pain and instability".Patient was revised from a size 4 tibia and 4x13 insert to a size 3 tibia with 12x50 stem and 3x19 ps insert.

• 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: joanne mahony ; ida industrial estate; carrigtwohill NA ; 214532800
• MDR Report Key: 7985047
• MDR Text Key: 124349170
• Report Number: 0002249697-2018-03445
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041491
• UDI-Public: 07613327041491
• 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
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5536B400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR