MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT PS#2 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5532G209
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Swelling (2091); Injury (2348)
Date of Event	09/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient was doing fantastic following surgery until last week when they developed a sinus infection.Patient went to er for sinus treatment and was put on antibiotics.A few days later patient developed pain, stiffness, swelling in knee and was worked up for an infection.I&d was performed with poly exchange.
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: patient acquired a secondary metastatic infectious complication of her fresh knee arthroplasty after a procedure for sinus infection in the upper respiratory tract requiring i&d with bearing exchange of the knee arthroplasty.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot or sterile lot referenced.Conclusions: a medical review of the provided information was completed by a clinician, this review concluded; patient acquired a secondary metastatic infectious complication of her fresh knee arthroplasty after a procedure for sinus infection in the upper respiratory tract requiring i&d with bearing exchange of the knee arthroplasty.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 required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient was doing fantastic following surgery until last week when they developed a sinus infection.Patient went to er for sinus treatment and was put on antibiotics.A few days later patient developed pain, stiffness, swelling in knee and was worked up for an infection.I&d was performed with poly exchange.

• Brand Name: X3 TRIATHLON INSERT PS#2 9MM
• 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: 6983043
• Report Number: 0002249697-2017-03116
• Device Sequence Number: 10924870
• Product Code: MBH
• UDI-Device Identifier: 07613327046205
• UDI-Public: 07613327046205
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

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: 04/18/2022
• Device Catalogue Number: 5532G209
• Device Lot Number: 9X4XW7
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 12/27/2017
• 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: 57 YR
• Patient Weight: 74