MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4 TRIATH TS PLUS TIB INS X3 POLY 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-416-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, 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 relevant reported discrepancies.There have been no other similar events for the lot referenced.The following devices were also listed in this report: device name#triathlon femoral distal augment 15mm - size 4 left ; cat#5542-a-401 ; lot#kmnu.Device name#tri press-fit stem 16x150mm ; cat# 5566-s-016 ; lot# m9l39g.Device name#triath total knee sys offset adapter 2mm ; cat#5570-s-020 ; lot#0068115d.Device name#tri ts femur sz4 left ; cat#5512-f-401 ; lot# buz4s.Device name#triathlon stem extender 25mm ; cat# 5571-s-025 ; lot# p83aev.Device name#tri post augment sz4 5mm ; cat#5543-a-400 ; lot#bgt9i.Device name#tri post augment sz4 5mm ; cat#5543-a-400 ; lot#bgt9i.Device name#triathlon stem extender 50mm ; cat# 5571-s-050 ; lot# yw4arn.Device name#triathlon femoral distal augment 15mm - size 4 left ; cat#5542-a-401 ; lot#vaeb.Device name#triathlon fem cone aug sz 4l ; cat#5549-a-341 ; lot#d5t5.Device name#triathlon stem extender 50mm ; cat# 5571-s-050 ; lot# d768my.Device name#tri ts baseplate size4 ; cat# 5521-b-400 ; lot#bxt4xa.Device name#triathlon stem extender 25mm ; cat# 5571-s-025 ; lot# ml5vvd.Device name#triathlon sym cone aug sz b ; cat#5549-a-120 ; lot#epa6.Device name#triath total knee sys offset adapter 4mm ; cat#5570-s-040 ; lot#0056033a.Device name#tri lm/rl tib aug sz3 5mm ; cat#5545-a-301 ; lot#erfaa5a.Device name#tri rm/ll tib aug sz4 10mm ; cat#5546-a-402 ; lot#ereml4d.Device name#tri rm/ll tib aug sz3 5mm ; cat#5545-a-302 ; lot#erffh8d.Device name#tri press-fit stem 15x150mm ; cat#5566-s-015 ; lot#0041488h.Device name#tri lm/rl tib aug sz4 10mm ; cat#5546-a-401 ; lot#eresa8a.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 the patient's left knee was revised due to infection.All implants were removed.

• Brand Name: NO 4 TRIATH TS PLUS TIB INS X3 POLY 16MM
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19282418
• Report Number: 0002249697-2024-00719
• Device Sequence Number: 15037587
• Product Code: MBH
• UDI-Device Identifier: 07613327287745
• UDI-Public: 07613327287745
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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-416-E
• Device Lot Number: YH4V06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/09/2024
• 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: 73 YR
• Patient Sex: Female