MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	5537-G-416
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	04/18/2019
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.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.The following devices were also listed in this report: tri ts femur sz5 right; cat# 5512-f-502; lot# uhid, tri ts baseplate size 4; cat# 5521-b-400; lot# tpida, dura duration all poly pat med; cat# 6642-2-100; lot# 00505332, triathlon femoral distal augment 5mm - size 5 right; cat# 5540-a-502; lot# inzs, triathlon femoral distal augment 5mm - size 5 right; cat# 5540-a-502; lot# gfzx, tri press-fit stem 18mm x 100mm; cat# 5565-s-018; lot# 0038667l, tri post augment sz5 5mm; cat# 5543-a-500; lot# mkpi, tri press-fit stem 15mm x 100mm; cat# 5565-s-015; lot# 0045948j, triathlon fem cone aug sz 3r; cat# 5549-a-332; lot# a85p, triathlon sym cone aug sz a; cat# 5549-a-110; lot# a9d0, tri lm/rl tib aug sz4 10mm; cat# 5546-a-401; lot# mc6v12e, tri rm/ll tib aug sz4 10mm; cat# 5546-a-402; lot# mc8k14h.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
This pi is for the revision of the patient's right knee due to infection on (b)(6) 2019.Procedure: the patient had a history of infected right knee replacement outside cors scope.Patient underwent resection arthroplasty with antibiotic cemet spacer to treat the infection (b)(6) 2016 off-label.Patient had second stage infection right total knee replacement (b)(6) 2016.Patient had mechanical problem right total knee revision surgery (b)(6) 2017 resection arthroplasty.Patient underwent chronically infected total knee arthroplasty revision with femoral component and patellar component (b)(6) 2019.

• Brand Name: NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9213431
• Report Number: 0002249697-2019-03560
• Device Sequence Number: 336294
• Product Code: MBH
• UDI-Device Identifier: 07613327027235
• UDI-Public: 07613327027235
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2019

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: 11/30/2020
• Device Catalogue Number: 5537-G-416
• Device Lot Number: 772NMX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 114