MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 31MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-631
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	08/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: tri ts femur sz6 right; cat# 5512-f-602; lot# ada3y.Tri post augment sz6 5mm; cat# 5543-a-600; lot# bab7z.Triathlon femoral distal augment 10mm - size 6 right; cat# 5541-a-602; lot# aax9g qty.2.Tri press-fit stem 18x150mm; cat# 5566-s-018; lot# 0062906j.Triathlon press-fit stem 22mm x 150mm; cat# 5566-s-022; lot# m8n47e.Triathlon total knee system offset adapter 2mm; cat# 5570-s-020; lot# 0068113m.Triathlon total knee system offset adapter 8mm; cat# 5570-s-080; lot# 0065803a.Tri ts baseplate size 6; cat# 5521-b-600; lot# bl79ea.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.
Event or Problem Description
It was reported that patient's right knee was revised due to possible infection (possible cause of infection, clinical confirmation not reported).An i&d with poly swap (same catalog number) was performed.

• Brand Name: NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 31MM
• 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: 7894643
• Report Number: 0002249697-2018-02976
• Device Sequence Number: 14044748
• Product Code: MBH
• UDI-Device Identifier: 07613327027457
• UDI-Public: 07613327027457
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2018

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: 09/30/2022
• Device Catalogue Number: 5537-G-631
• Device Lot Number: W41K97
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/20/2018
• 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: 54 YR
• Patient Weight: 114