MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 3 TRIATH TS PLUS TIB INS X3 POLY 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-313-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
I&d with tibial insert swap of a ts right knee due to infection.
Additional Manufacturer Narrative
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: 5551-g-320-e triathlon asymmetric x3 patella 8wnx 5521-b-300 tri ts baseplate size 3 oyu3ya 5545-a-302 tri rm/ll tib aug sz3 5mm xl78954a 5570-s-020 triath total knee sys offset adapter 2mm 0087332d 5571-s-025 triathlon stem extender 25mm et33dv 5565-s-016 tri press-fit stem 16mm x 100mm 0137766d 5565-s-019 tri press-fit stem 19mm x 100mm 0124096a 5512-f-302 tri ts femur sz3 right ose9t 5544-a-300 tri post augment sz3 10mm geh9b 5544-a-300 tri post augment sz3 10mm lxi3r 5542-a-302 triathlon fem dist aug 15mm size 3 right io73y 5541-a-302 triathlon fem dist aug 10mm size 3 right llo4t 5570-s-020 triath total knee sys offset adapter 2mm 0118117j it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : not returned.

• Brand Name: NO 3 TRIATH TS PLUS TIB INS X3 POLY 13MM
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18702566
• Report Number: 0002249697-2024-00225
• Device Sequence Number: 17690868
• Product Code: MBH
• UDI-Device Identifier: 07613327287974
• UDI-Public: 07613327287974
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2024

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: 5537-G-313-E
• Device Lot Number: K918WE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male