MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #4 CS ALLPOLY 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5534-A-416
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/04/2021
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# 5510f401; triathlon cr fem comp #4 l-cem; lot# j2n7h.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient had bilateral index tka (outside of cors scope (b)(6) 2011).Had a pji of both knees.Undergoes revision on (b)(6) 2020 with all components exchanged, and antibiotic cement loaded for treatment.Patient returns for a left pji knee revision on (b)(6) 2021.All components exchanged.
Additional Manufacturer Narrative
Correction: mfr report #0002249697-2021-01882 was reported in error.This pi reports the removal of a temporary spacer (stage 2).The revision for infection involved devices of an unknown manufacturer.Insufficient information was provided and no additional information is available, therefore, this complaint is being canceled.
Event or Problem Description
Correction: this event was reported in error.This pi reports the removal of a temporary spacer (stage 2).The revision for infection involved devices of an unknown manufacturer.Insufficient information was provided and no additional information is available, therefore, this complaint is being canceled.Patient had bilateral index tka (outside of cors scope (b)(6), 2011).Had a pji of both knees.Undergoes revision on (b)(6), 2020 with all components exchanged, and antibiotic cement loaded for treatment.Patient returns for a left pji knee revision on (b)(6) 2021.All components exchanged.

• Brand Name: TRIATHLON #4 CS ALLPOLY 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12808412
• Report Number: 0002249697-2021-01882
• Device Sequence Number: 11956504
• Product Code: MBH
• UDI-Device Identifier: 07613327043280
• UDI-Public: 07613327043280
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

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: 08/31/2024
• Device Model Number: 5534-A-416
• Device Catalogue Number: 5534A416
• Device Lot Number: 462228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 11/14/2021
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2019
• 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; Other; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White