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

Catalog Number 5530-G-511

Device Problems Material Discolored (1170); Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 10/06/2014

Event Type  Injury  

Event Description

Total knee revision due to infection.No evidence or suspicion of implant failure.All prosthesis were removed & antibiotic cement spacer was implanted.Original operation was done on (b)(6) 2013.I noticed yellowing on poly surface & felt it was worth investigating what the cause of the yellowing was.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method and results: device evaluation and results: the component visually appears to be consistent with a device that was in vivo and subsequently explanted.Material analysis of the device indicated that in vivo service-related material damage to the articulating surface of the tibial insert was observed.The tibial also had yellow discoloration throughout its entire surface, likely due to the in vivo absorption and accumulation of synovial fluid inside the insert material.Explantation damage on the distal insert surface was also present.No material or manufacturing defects were observed on the device features examined.Medical records received and evaluation: not performed as no medical records were provided.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 lot and sterile lot referenced.Conclusions: the reported event could not be confirmed with the limited information provided.Further information such as x-rays, operative reports, patient history, follow-up notes and pathology reports are needed to complete the investigation for determining a root cause.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 following other devices were added to this report: triathlon p/a cr beaded #5r; cat# 5517f502; lot# ecjyc; triathlon prim cem fxd bplt #5; cat# 5520b500; lot# edanh.It cannot be determined which, if any of these devices may have caused or contributed to the patient's infection.

Event Description

Total knee revision due to infection.No evidence or suspicion of implant failure.All prosthesis were removed & antibiotic cement spacer was implanted.Original operation was done in (b)(6) 2013.I noticed yellowing on poly surface and felt it was worth investigating what the cause of the yellowing was.

• 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: 4215492
• MDR Text Key: 18000449
• Report Number: 0002249697-2014-04086
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2014

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: 05/31/2018
• Device Catalogue Number: 5530-G-511
• Device Lot Number: MMJ2J1
• Other Device ID Number: STERILE LOT# MSGMJ16J4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 10/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2013
• 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