MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 19MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G419

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fall (1848); Swelling (2091); Injury (2348)

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.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

Patient fell multiple times after surgery on her left knee done in (b)(6) 2015.On the last fall she felt something tear.Called doctors' office, said she couldn't make her appointment and sat at home for unknown amount of days before she made it to the doctors' office.At that time she had 2 wounds to her knee that communicated into the joint.Upon examination of her right knee, doctor noticed swelling and redness so scheduled surgery for that night to washout both knees, swap both liners and repairing patella tendon on left knee as well.This pi is for the right knee revision.

Manufacturer Narrative

An event regarding infection involving a triathlon insert in the right knee was reported.The event was confirmed by a patient note.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: multiple patient trauma with repetitive falls have caused disturbance of the surgical knee wound with deep joint infection.On the left side also the patellar ligament ruptured.Both conditions required surgical procedure with i&d plus bearing exchange while the left patellar tendon was repaired as well.Device history review: the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar reported events for the lot or sterile lot referenced.Conclusions: the patient had bilateral tka, experienced several falls, tore a ligament in the left knee and developed infection in both knees which led to revision surgery.A washout was completed and the reported inserts were exchanged with the same type and thickness insert in both knees.The torn patella tendon was repaired in the left knee.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.A capa trend analysis was conducted for the reported failure mode and concluded infection is a known possible adverse outcome of surgery and is beyond stryker's control.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

Patient fell multiple times after surgery on her left knee done in (b)(6) 2015.On the last fall she felt something tear.Called doctors' office, said she couldn't make her appointment and sat at home for unknown amount of days before she made it to the doctors' office.At that time, she had 2 wounds to her knee that communicated into the joint.Upon examination of her right knee, doctor noticed swelling and redness so scheduled surgery for that night to washout both knees, swap both liners and repairing patella tendon on left knee as well.This pi is for the right knee revision.

• Brand Name: X3 TRIATHLON CS INS SIZE4 19MM
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5371200
• MDR Text Key: 36207845
• Report Number: 0002249697-2016-00110
• 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: 12/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 5531G419
• Device Lot Number: LCP153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2011
• 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: 51 YR
• Patient Weight: 122