MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5537-G-319
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a right tka outside cors scope in 2013, required an mua one month later.The patient developed pji with mssa and later with mrsa.Has been revised 5 times out of cors scope.In (b)(6) 2017 the patient is reimplanted, now entering cors registry.Patient develops again pji and instability.Patient undergoes resection and revision on (b)(6) 2021.
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# 5512-f-302: tri ts femur sz3 right; lot# aal7g, cat# 5521-b-300; tri ts baseplate size 3; lot# aih3zb, cat# 5560-s-215; triathlon cemented stem-15mm x 100mm; lot# 0045717a, cat# 5543-a-300; tri post augment sz3 5mm; lot# ahg7a , cat# 5540-a-302; triathlon femoral distal augment 5mm - size 3 right; lot# wegv, cat# 5560-s-112; tri cemented stem 12mmx50mm; lot# 0052029j, cat# 5543-a-300; tri post augment sz3 5mm; lot# aht7u, and cat# 5541-a-302; triathlon femoral distal augment 10mm - size 3 right; lot# mhek.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
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# 5512-f-302: tri ts femur sz3 right; lot# aal7g, cat# 5521-b-300; tri ts baseplate size 3; lot# aih3zb, cat# 5560-s-215; triathlon cemented stem-15mm x 100mm; lot# 0045717a, cat# 5543-a-300; tri post augment sz3 5mm; lot# ahg7a , cat# 5540-a-302; triathlon femoral distal augment 5mm - size 3 right; lot# wegv, cat# 5560-s-112; tri cemented stem 12mmx50mm; lot# 0052029j, cat# 5543-a-300; tri post augment sz3 5mm; lot# aht7u, and cat# 5541-a-302; triathlon femoral distal augment 10mm - size 3 right; lot# mhek.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient had a right tka outside cors scope in 2013, required an mua one month later.The patient developed pji with mssa and later with mrsa.Has been revised 5 times out of cors scope.In (b)(6) 2017 the patient is reimplanted, now entering cors registry.Patient develops again pji and instability.Patient undergoes resection and revision on (b)(6) 2021.

• Brand Name: NO 3. 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13597575
• Report Number: 0002249697-2022-00278
• Device Sequence Number: 1930602
• Product Code: MBH
• UDI-Device Identifier: 07613327027167
• UDI-Public: 07613327027167
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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: 07/31/2021
• Device Model Number: 5537-G-319
• Device Catalogue Number: 5537-G-319
• Device Lot Number: Y131NR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American