MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5532-G-611

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

An event regarding infection involving a tibial insert was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.There have been no other similar events for the sterile lot referenced.Conclusion: infection is a known possible adverse outcome of surgery, as noted in the instructions for use.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.When the sterile barrier of any device is opened, the sterility of that device becomes a function of handling and surgical technique and is beyond stryker¿s control.Infection due to bacterial contamination, as supplied from the manufacturer, is an extremely rare event.If further information becomes available or the product is returned, this investigation will be re-opened.The following devices were also listed in this report: triathlon ps x3 tibial insert; cat# 5551-g-381; lot# rnmx.Triathlon ps fem comp #7r-cem; cat# 5515f702; lot# d6b4n.Tri ts baseplate size 6; cat# 5521-b-600; lot# dgu7ba.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.

Event Description

It was reported that a stage 1 revision was performed on the patient's right knee due to infection.The patient's knee construct was removed and a spacer was placed.Rep reported that no further information will be available.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9819529
• MDR Text Key: 188808939
• Report Number: 0002249697-2020-00503
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050851
• UDI-Public: 07613327050851
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 5532-G-611
• Device Catalogue Number: 5532-G-611
• Device Lot Number: 9M6PTE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2019
• 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: 57 YR
• Patient Weight: 157