MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; IMPLANT

Catalog Number 5530-G-416

Device Problem Human-Device Interface Problem (2949)

Patient Problems Unspecified Infection (1930); Tissue Damage (2104); Complaint, Ill-Defined (2331)

Event Date 07/01/2014

Event Type  Injury  

Event Description

Surgeon reports patient who is a status post left total knee (b)(6) 2008 was bitten by a dog and now has an infected knee.Surgeon requested to have inserts available to exchange.Surgeon proceeded to open the knee wash it out and perform an insert exchange.The surgery went without incident.Height 167cm weight 84kg.Explanted implant was sent to pathology per or protocol.

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown insert component.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Device not returned to manufacturer.

Manufacturer Narrative

An event regarding infection involving a triathlon cr insert was reported.The event was not confirmed.Visual, dimensional, and functional inspections were not performed as no items were returned.A dhr found that the device was manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot and sterile lot referenced.The exact cause of the event could not be determined because insufficient information was provided.A capa trend analysis was concluded infection is a known possible adverse outcome of surgery and is beyond stryker's control.No further investigation is required at this time.

Event Description

Surgeon reports patient who is a status post left total knee (b)(6) 2008 was bitten by a dog and now has an infected knee.Surgeon requested to have inserts available to exchange.Surgeon proceeded to open the knee wash it out and perform an insert exchange.The surgery went without incident.(b)(6).Explanted implant was sent to pathology per operating room protocol.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ 07430 NA
• Manufacturer Contact: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3941645
• MDR Text Key: 4579886
• Report Number: 0002249697-2014-02791
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2012
• Device Catalogue Number: 5530-G-416
• Device Lot Number: EHHMED
• Other Device ID Number: MG0703R045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2007
• 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: 85 YR
• Patient Weight: 84