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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); Injury (2348)
Date of Event	11/09/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Wound dehiscence and joint infection after left tkr.
Additional 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 or Problem Description
Wound dehiscence and joint infection after left tkr.

• Brand Name: X3 TRIATHLON CS INSERT #7 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6605829
• Report Number: 0002249697-2017-01749
• Device Sequence Number: 11015493
• Product Code: MBH
• UDI-Device Identifier: 07613327046038
• UDI-Public: (01)07613327046038(11)151206(17)201206(10)LET405
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 08/13/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 126