MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE 4 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number 5531G409

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Fall (1848); Fever (1858); Unspecified Infection (1930); Pain (1994); Discomfort (2330)

Event Date 03/03/2016

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: tri ts baseplate size 4; cat# 5521-b-400; lot# mgbra.Triathlon cr fem comp #4 r-cem; cat# 5510-f-402; lot# el47r.Sterile fluted headless 1/8" pin 3.5" long; cat# 7650-2038a; lot# rd9n067j.Simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# miv070.Simplex p full dose 1 pack; cat# 6191-1-001; lot# rjv125.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.

Event Description

The patient states that she fell on to her left knee on this past monday.On tuesday, she and her daughter went to (b)(6) hospital where x-rays of the knees were reportedly negative, and she was told to follow up in the clinic with orthopedic surgery.She continued to have left knee pain and some subjective fevers up to 101 and inability to bear weight, thus she called our office and we instructed her to come to (b)(6) hospital emergency department.At that point, she was found to have increased infectious markers, including sedimentation rate and white blood cell count.The left knee was aspirated and found to have over 200,000 nucleated cells with 79% polymorphonuclear cells.She was also having some discomfort in the right knee, thus an aspiration was performed of this knee, which showed 45,000 nucleated cells with a high poly count as well.

Manufacturer Narrative

An event regarding infection involving a triathlon cs insert was reported.The event was confirmed.Method & results: device evaluation and results: not performed as the device was not returned for evaluation.Medical records received and evaluation: a review indicated that a fall on the knee caused a breach of the skin barrier allowing bacteria to enter the body of a patient with multiple risk factors for infection including diabetes and poor nutritional status.Revision surgery was required with i&d plus bearing exchange of the right knee while the non-stryker devices in the infected left knee were completely removed with implantation of an antibiotic spacer as first stage of a two-stage infection treatment.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 reported sterile lot or lot id.Conclusions: the investigation concluded that a fall on the knee caused a breach of the skin barrier allowing bacteria to enter the body of a patient with multiple risk factors for infection including diabetes and poor nutritional status.Revision surgery was required with i&d plus bearing exchange of the right knee while the non-stryker devices in the infected left knee were completely removed with implantation of an antibiotic spacer as first stage of a two-stage infection treatment.No further investigation for this event is possible at this time as no devices were received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.Product surveillance will continue to monitor for trends.

Event Description

The patient states that she fell on to her left knee on this past monday.On tuesday, she and her daughter went to (b)(6) hospital where x-rays of the knees were reportedly negative, and she was told to follow up in the clinic with orthopedic surgery.She continued to have left knee pain and some subjective fevers up to 101 and inability to bear weight, thus she called our office and we instructed her to come to (b)(6) hospital emergency department.At that point, she was found to have increased infectious markers, including sedimentation rate and white blood cell count.The left knee was aspirated and found to have over 200,000 nucleated cells with 79% polymorphonuclear cells.She was also having some discomfort in the right knee, thus an aspiration was performed of this knee, which showed 45,000 nucleated cells with a high poly count as well.

• Brand Name: X3 TRIATHLON CS INS SIZE 4 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5570870
• MDR Text Key: 42438058
• Report Number: 0002249697-2016-01200
• 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: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 5531G409
• Device Lot Number: LEW831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2016
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 37