MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 22MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-522
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This pi is for the revision on (b)(6) 2021.Patient had left index tka (outside of cors scope).Patient has had multiple revisions (outside of cors scope) for instability.On (b)(6) 2021 the patient is admitted for revision due to instability.Undergoes revision of all components.On (b)(6) 2021 the patient presents with left pji and is revised with exchange of poly only and with antibiotic loaded cement for treatment.On (b)(6) 2021, the patient undergoes second revision for left pji with poly exchange only.
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: tri ts femur sz6 left; cat# 5512-f-601; lot# gub4s.Tri ts baseplate size 5; cat# 5521-b-500; lot# gud3sa.Triathlonctrfemconeaug sz 6l; cat# 5549-a-661; lot# me561.Triathlon sym cone aug sz e; cat# 5549-a-150; lot# nk6p1.Tri press-fit stem 21x150mm; cat# 5566-s-021; lot# 0079555h.Tri post augment sz6 10mm; cat# 5544-a-600; lot# wtzu.Triathlon femoral distal augment 10mm - size 6 left; cat# 5541-a-601; lot# ggs9g.Tri rm/ll tib aug sz5 5mm; cat# 5545-a-502; lot# erawp0a.Tri press-fit stem 15x150mm; cat# 5566-s-015; lot# 0076554l.Tri post augment sz6 10mm; cat# 5544-a-600 ; lot# wtzu.Triathlon femoral distal augment 15mm - size 6 left; cat# 5542-a-601; lot# wtra.Tri lm/rl tib aug sz5 10mm; cat# 5546-a-501; lot# erfcv8d.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: X3 TRIATHLON CS INSERT #5 22MM
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12808407
• Report Number: 0002249697-2021-01878
• Device Sequence Number: 4778115
• Product Code: MBH
• UDI-Device Identifier: 07613327045925
• UDI-Public: 07613327045925
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2021

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: 01/21/2022
• Device Model Number: 5531-G-522
• Device Catalogue Number: 5531G522
• Device Lot Number: LFN249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2017
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: Black Or African American