MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SYMMETRIC X3 PATELLA; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number 5550-G-360

Device Problem Loss of Osseointegration (2408)

Patient Problems Unspecified Infection (1930); Sepsis (2067); Synovitis (2094); Injury (2348)

Event Date 05/18/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.There have been no other events for the sterile lot referenced.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

It was discovered during a monitoring visit for a stryker triathlon cones outcomes study (a revision study): patient had a deep wound infection starting a few days prior to hospitalization on (b)(6) 2017.Patient was admitted for debridement and antibiotic treatment.Patient went to operating room on (b)(6) 2017 for septic knee with: irrigation and debridement, synovectomy, polyethylene liner exchange, removal of loose patellar implant and retained patellar cement.Cultures positive for (b)(6).Patient also had cardiac complication during same admission.

Manufacturer Narrative

An event regarding alleged loosening and infection involving a triathlon patella was reported.The event was confirmed.Device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: a review of the provided past medical history and operative report by a consulting clinician indicated: "subject had a deep wound infection.Admitted for debridement and antibiotic treatment, synovectomy, poly exchange, removal loose patella implant and cement.Cultures positive for methacycline sensitive staph aureus and long-term antibiotic started." "there is no follow-up subsequent to the (b)(6) 2017 operative report and no x-rays or earlier operative reports prior to (b)(6) 2017 surgery.There is no indication that the post-operative periprosthetic infection of the revision right total knee arthroplasty was related to factors of faulty component design, manufacturing or materials." device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.There is no deviation found after review of sterilization records.Complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: the source of the infection could not be determined as patient information, clinical history, and results of bloodwork for infection were not provided.A review of the provided past medical history and operative report by a consulting clinician indicated "there is no follow-up subsequent to the (b)(6) 2017 operative report and no x-rays or earlier operative reports prior to (b)(6) 2017 surgery.There is no indication that the post-operative periprosthetic infection of the revision right total knee arthroplasty was related to factors of faulty component design, manufacturing or materials." 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.The internal investigation of sterilization process and records confirmed the product met sal 10-6 per corresponding iso standards.No further investigation is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

Event Description

It was discovered during a monitoring visit for a stryker triathlon cones outcomes study (a revision study): patient had a deep wound infection starting a few days prior to hospitalization on (b)(6) 2017.Patient was admitted for debridement and antibiotic treatment.Patient went to or on (b)(6) 2017 for septic knee with irrigation and debridement, synovectomy, polyethylene liner exchange, removal of loose patellar implant and retained patellar cement.Cultures (b)(6) for (b)(6).Patient also had cardiac complication during same admission.

• Brand Name: TRIATHLON SYMMETRIC X3 PATELLA
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6740574
• MDR Text Key: 80926119
• Report Number: 0002249697-2017-02274
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327014778
• UDI-Public: 07613327014778
• 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: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2021
• Device Catalogue Number: 5550-G-360
• Device Lot Number: LNJW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 115