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

Catalog Number 5532-G-413

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 11/25/2015

Event Type  Injury  

Manufacturer Narrative

The following other devices were also listed in this report: tri cemented stem 12mmx50mm; cat# 5560-s-112; lot# 0036905i.Tri lm/rl tib aug sz4 5mm; cat# 5545-a-401; lot# fuhha.Tri rm/ll tib aug sz4 5mm; cat# 5545-a-402; lot# er9km7e.Triathlon symmetric x3 patella; cat# 5550-g-319; lot# kp9t.Tri ts baseplate size 4; cat# 5521-b-400; lot# tbv3a.Triathlon ps fem component, cemented; cat# 5515-f-401; lot# mrrrsw3a.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 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.

Event Description

Due to infection dr swapped poly and irrigated left knee.

Manufacturer Narrative

An event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method and results: device evaluation and results: could not be performed as no items associated with the event were returned or made available for evaluation.Medical records received and evaluation: insufficient medical records were received for review with a clinical consultant.Device history review: indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced and the sterile lot.Conclusions: the source of the infection could not be determined as patient information, clinical history, and results of blood work for infection were not provided.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.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Due to infection doctor swapped poly and irrigated left knee.

• Brand Name: TRIATHLON PS 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: 5312262
• MDR Text Key: 33923691
• Report Number: 0002249697-2015-04313
• 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: 11/25/2015

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: 05/31/2019
• Device Catalogue Number: 5532-G-413
• Device Lot Number: MNJLTD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2014
• 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: 49 YR
• Patient Weight: 121