MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CS #7 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	5531-G-710-E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no product was returned for evaluation.Clinician review: no medical records were received for review with a clinical consultant device history review: not performed as no lot code information was provided.Complaint history review: not performed as no lot code information was provided.Conclusions: it was reported that the patient was revised due to infection.The event could not be confirmed nor the exact cause of the event could be determined because insufficient information was provided.Although the device information is not provided, all stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10-6 in accordance to applicable iso standards.Further information such as device lot identification and return, pathology reports including the strain of infection identified, pre- and post-operative x-rays,operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Device not returned.
Event or Problem Description
It was reported that the patient's right knee was revised due to infection (infection reported by surgeon.Unknown if clinically confirmed or if infecting microorganism identified).Surgeon performed a poly swap of a 7 x 10 cs insert for another 7 x 10 cs insert.Rep reported that no further information will be available.

• Brand Name: X3 TRIATHLON INSERT CS #7 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9311422
• Report Number: 0002249697-2019-03737
• Device Sequence Number: 14046772
• Product Code: JWH
• UDI-Device Identifier: 07613327392234
• UDI-Public: 07613327392234
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K173849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2019

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 Catalogue Number: 5531-G-710-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/12/2019
• 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: 53 YR
• Patient Weight: 147