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 Problems Detachment Of Device Component (1104); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problem Unspecified Infection (1930)

Event Date 05/03/2016

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: triathlon cr fem comp #5 l-cem; cat# 5510-f-501; lot# all6t; triathlon prim cem fxd bplt #5; cat# 5520-b-500; lot# alx9f; triathlon asymmetric x3 patella; cat# 5551-g-350; lot# ky3h; it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was retained by the hospital and was not returned to the manufacturer.Additional information has been requested.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

Revision of left total knee due to infection.All components came out.

Manufacturer Narrative

Reported event: an event regarding infection involving a triathlon insert component was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as the device was not returned for evaluation.Medical records received and evaluation: not performed as medical records were not received.Device history review: dhr review was satisfactory.Complaint history review: chr review confirmed that there were no other similar reported events for the reported lot codes.Conclusions: a limited investigation was performed as minimal information was received.Further information such as x-rays, medical records, operative notes and pathology reports are required to further investigate this event.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.If devices and/or additional information become available, this investigation will be reopened.Product surveillance will continue to monitor for trends.

Event Description

Revision of left total knee due to infection.All components came out.

• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5689385
• MDR Text Key: 46252065
• Report Number: 0002249697-2016-01761
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 5530-G-509
• Device Lot Number: MNDKA8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2014
• 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: 59