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

Catalog Number 5530-G-509

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

The following other devices were also listed in this report: triathlon asymmetric x3 patella; cat# 5551-g-350; lot# 0y84.Triathlon prim cem fxd bplt #5; cat# 5520b500; lot# stm8d.Triathlon cr fem comp #5 r-cem; cat# 5510f502; lot# sstfs.It cannot be determined which, if any of these devices may have caused or contributed to the patient's infection.An evaluation of the device cannot be performed as the device was sent to pathology and was not returned to the manufacturer.Additional information has been requested, but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

Dr.(b)(6).Reports patient a status post right total knee done (b)(6) 2010 has signs of an infection and he would like to irrigate and debride as well as perform a poly insert exchange.

Manufacturer Narrative

An event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: not performed as medical records were not 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 similar reported events for the lot or sterile lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pre- and post-operative x-rays, pathology reports, operative reports as well as patient history and follow-up notes 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.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Dr.(b)(6) reports patient a status post right total knee done (b)(6) 2010 has signs of an infection and he would like to irrigate and debride as well as perform a poly insert exchange.

• Brand Name: TRIATHLON CR 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5302783
• MDR Text Key: 33648631
• Report Number: 0002249697-2015-04261
• Device Sequence Number: 1
• Product Code: MBH
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: 5530-G-509
• Device Lot Number: MJLATH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2010
• 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: 81 YR
• Patient Weight: 60