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

Model Number	5530-G-609-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: cat# 5517f502; triathlon p/a cr beaded #5r; lot# ll64c1.Cat# 5536b600; tritanium bplate triathlon s6; lot# ctd56347.Cat# 5552-l-381; tritanium patella-asymmetric; lot# nd1e1.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that a stage 1 revision was performed on the patient's right knee due to infection.All implants were removed and an antibiotic spacer was placed.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: no product was returned however photographs were provided.The photographs show recently explanted baseplate, femoral component, insert and patella, explantation damage is visible on the insert and locking wire is removed.Bony ingrowth is visible on the posterior/underside of the patella and baseplate.Bone cement is visible on the posterior/underside of the femoral component.Clinician review:- no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: it was reported that the patient was revised due to infection.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Additional information including pathology reports, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that a stage 1 revision was performed on the patient's right knee due to infection.All implants were removed and an antibiotic spacer was placed.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13660955
• Report Number: 0002249697-2022-00312
• Device Sequence Number: 17395675
• Product Code: MBH
• UDI-Device Identifier: 07613327383133
• UDI-Public: 07613327383133
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

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: 01/31/2026
• Device Model Number: 5530-G-609-E
• Device Catalogue Number: 5530-G-609-E
• Device Lot Number: Y95W50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male