MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-516
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	09/20/2019
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 sz4 left; cat# 5512-f-401; lot# blt9y, tri ts baseplate size 5; cat# 5521-b-500; lot# btv9sa, triathlon femoral distal augment 10mm - size 4 left; cat# 5541-a-401; lot# abx3s, triathlon femoral distal augment 10mm - size 4 left; cat# 5541-a-401; lot# abx3s, tri post augment sz4 5mm; cat# 5543-a-400; lot# axr3l, tri post augment sz4 5mm; cat# 5543-a-400; lot# bdv7t, tri rm/ll tib aug sz5 5mm; cat# 5545-a-502; lot# erenl3a, tri rm/ll tib aug sz5 5mm; cat# 5545-a-501; lot# erewp5d, tri cemented stem 12mmx100mm; cat# 5560-s-212; lot# 0041497e, sterile fluted headless 1/8" pin 3.5" long; cat# 7650-2038a; lot# rdct112a, md.Univ.Cement restrictor w/di; cat# b000-1240; lot#6m9589, md.Univ.Cement restrictor w/di; cat# b000-1240; lot#6m9589.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported the patient's knee was revised due to bloodborne infection (infection reported by surgeon.Unknown if clinically confirmed or identified).A poly swap of a 5 x 16 ts insert was performed.Rep provided usage sheets from current and prior procedures and reported that no further information will be available.

• Brand Name: NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 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
• MDR Report Key: 9202378
• Report Number: 0002249697-2019-03533
• Device Sequence Number: 18934897
• Product Code: MBH
• UDI-Device Identifier: 07613327027327
• UDI-Public: 07613327027327
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2019

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: 12/31/2020
• Device Catalogue Number: 5537-G-516
• Device Lot Number: XM3NPJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/17/2019
• 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: 73