MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5531-G-711

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Injury (2348)

Event Date 11/09/2016

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: triathlon p/a cr beaded #6l; cat# 5517-f-601; lot# ayr2h, triathlon symmetric x3 patella; cat# 5550-g-319; lot# 5t9h, tritanium bplate triathlon s7; cat# 5536-b-700; lot# ejdxp.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Wound dehiscence and joint infection after left tkr.

Manufacturer Narrative

An event regarding infection involving a triathlon insert was reported.The event was confirmed.Method & results: device evaluation and results: not performed as the device was not returned for evaluation.Medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated "the primary harm involved is wound complication with infection.No implant or manufacturing issues were identified.Complication most likely related to pre-existing patient related risk factors for wound complication/infection." device history review: the devices were manufactured and accepted into final stock with no reported discrepancies complaint history review: there have been no other events for the lot or sterile lot referenced.Conclusions: the event was confirmed as per provided medical assesment by the consulting clinician who indicated that the primary harm involved is wound complication with infection.No implant or manufacturing issues were identified.Complication most likely related to pre-existing patient related risk factors for wound complication/infection.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Wound dehiscence and joint infection after left tkr.

• Brand Name: X3 TRIATHLON CS INSERT #7 11MM
• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6605829
• MDR Text Key: 76451029
• Report Number: 0002249697-2017-01749
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327046038
• UDI-Public: (01)07613327046038(11)151206(17)201206(10)LET405
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

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: 12/06/2020
• Device Model Number: 5531-G-711
• Device Catalogue Number: 5531G711
• Device Lot Number: LET405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: 08/13/2017
• Supplement Dates FDA Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 126