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

Catalog Number	5530-G-313
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer however, explant photos show wear of the device.Without additional information the root cause for this event cannot be established.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's right knee was revised due to poly wear.A 3x13 cr insert was revised to a 3x13 cs insert.Rep provided explant pictures and reported that no further information will be available.
Event or Problem Description
It was reported that the patients right knee was revised due to poly wear.A 3x13 cr insert was revised to a 3x13 cs insert.Rep provided explant pictures and reported that no further information will be available.
Additional Manufacturer Narrative
An event regarding wear involving a triathlon insert was reported.The event was confirmed by photographs.Method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows an explanted triathlon insert of catalog number 5530-g-313.There are scratching marks on the insert surface.One end of the anterior part is delaminated with blood on it.The insert surface is yellow colored.Clinician review: no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: this event is confirmed based on the provided photographs.The insert was revised after approximately 12 years usage.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, clinical reports, histopathology reports, office notes and serial x-rays are needed to fully investigate the event.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: 8637993
• Report Number: 0002249697-2019-02095
• Device Sequence Number: 11285417
• Product Code: MBH
• UDI-Device Identifier: 07613327050455
• UDI-Public: 07613327050455
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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: 5530-G-313
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/21/2019
• 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: 65 YR