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

Catalog Number 5530-G-309

Device Problem Material Discolored (1170)

Patient Problem Unspecified Infection (1930)

Event Date 10/20/2014

Event Type  Injury  

Event Description

Booked knee revision for liner change and washout for possible infection.Insert removed insert shows some mild yellow discolouration, and has been returned to stryker for investigation.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events reported for the reported manufacturing lot and sterile lot visual inspection was performed as part of the material analysis report (mar).Burnishing, scratching, and third-body indentations were observed on the insert and are a commonly identified damage modes on uhmwpe inserts.Yellow discoloration was observed that has been associated with the in vivo absorption of synovial fluids.No evidence of manufacturing or material defects was observed on the returned ultra-high molecular weight polyethylene (uhmwpe) tibial insert.The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.A capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.

Event Description

Booked knee revision for liner change and washout for possible infection.Insert removed insert shows some mild yellow discolouration, and has been returned to stryker for investigation.

• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4247845
• MDR Text Key: 5104707
• Report Number: 0002249697-2014-04255
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K051146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/20/2014

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: 10/31/2018
• Device Catalogue Number: 5530-G-309
• Device Lot Number: MMPVLP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 11/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• 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: 84 YR
• Patient Weight: 65