MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/14/2020
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# 5510f502; triathlon cr fem comp #5 r-cem; lot# aas9b.Cat# 5521-b-500; tri ts baseplate size 5; lot# ao33aa.Cat# 5549-a-352; triathlon fem cone aug sz 5r; lot# a62e.Cat# 5560-s-212; tri cemented stem 12mmx100mm; lot# 0044801j.Cat# 5560-s-112; tri cemented stem 12mmx50mm; lot# 0055980a.Cat# 5543-a-500; tri post augment sz5 5mm; lot# wie3.Cat# 5549-a-120; triathlon sym cone aug sz b; lot# amm7.Cat# 6195-1-001; simplex hv with gentamicin us 1 pack; lot# 702bb824ay qty 5.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
As reported: "doctor performed a right knee revision on (b)(6) 2020.Original date of ts surgery (b)(6) 2017.Reason for revision is infection.No more information is available per doctor." rep provided the primary implant sheet.A 5x13 ts insert was revised.

• Brand Name: NO 5. TRIATHLON TS PLUS TIBIAL INSERT 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
• MDR Report Key: 11129636
• Report Number: 0002249697-2021-00045
• Device Sequence Number: 13662294
• Product Code: MBH
• UDI-Device Identifier: 07613327027310
• UDI-Public: 07613327027310
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2021

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: 02/28/2022
• Device Model Number: 5537-G-513
• Device Catalogue Number: 5537-G-513
• Device Lot Number: 424J28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 01/07/2021
• 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: 66 YR
• Patient Weight: 64