MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 2. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-219
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Catalog numbers and lot codes of other devices listed in this report: 5512-f-302 tri ts femur sz3 right, teby; 5566-s-015 tri press-fit stem 15x150mm, m9m37d; 5540-a-302 triathlon femoral distal augment 5mm - size 3 right ioha; 5540-a-302 triathlon femoral distal augment 5mm - size 3 right ioha; 5543-a-300 tri post augment sz3 5mm suad; 5543-a-300 tri post augment sz3 5mm kubz; 5549-a-342 triathlon fem cone aug sz 4r, a663; 5521-b-200 tri ts baseplate size 2, mtnpd; 5549-a-140 triathlon sym cone aug sz d, a5py; 5566-s-015 tri press-fit stem 15x150mm, m9l38d.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.  a supplemental report will be submitted upon comcatalog numbers and lot codes of other devices listed in this report: 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.Device not returned.
Event or Problem Description
It was reported that a stage 1 revision was performed on the patient's right knee due to infection.All components were removed and a static spacer was placed.Rep provided the primary usage sheet and confirmed that no further information will be available.

• Brand Name: NO 2. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM
• 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: 9258104
• Report Number: 0002249697-2019-03647
• Device Sequence Number: 3731694
• Product Code: MBH
• UDI-Device Identifier: 07613327027075
• UDI-Public: 07613327027075
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2019

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: 09/30/2020
• Device Catalogue Number: 5537-G-219
• Device Lot Number: XW0R98
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/30/2019
• 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: 68 YR
• Patient Weight: 101