MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5 TRIATH TS PLUS TIB INS X3 POLY 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-509-E
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Laxity (4526)
Date of Event	06/25/2025
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: triathlon asymmetric x3 patella; cat# 5551-g-299-e ; lot# nl2v tri ts femur sz4 right; cat# 5512-f-402 ; lot# l339t triath fem distal aug 5mm - size 4 right; cat# 5540-a-402 ; lot# g9g4r tri post augment sz4 5mm; cat# 5543-a-400 ; lot# h7r9t tri post augment sz4 5mm; cat# 5543-a-400 ; lot# h7r9t triath fem distal aug 5mm - size 4 right; cat# 5540-a-402 ; lot# hal4b triathlon sym cone aug sz a; cat# 5549-a-110; lot# u2321 triathlon cemented stem-15mm x 50mm; cat# 5560-s-115; lot# 1130464l tri rm/ll tib aug sz5 5mm; cat# 5545-a-502; lot# xl76144a tri lm/rl tib aug sz5 5mm; cat# 5545-a-501; lot# erhwy6a triathlon sym cone aug sz c; cat# 5549-a-130; lot# u52e1 tri ts baseplate size 5; cat# 5521-b-500; lot# oxr7ia tri cemented stem 12mmx50mm; cat# 5560-s-112; lot# 1142411m 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 that the patient's right knee was revised due to possible infection and instability.A 5x9 ts insert was revised to a 5x16 ts insert.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: NO 5 TRIATH TS PLUS TIB INS X3 POLY 9MM
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 22737587
• Report Number: 0002249697-2025-00847
• Device Sequence Number: 12562392
• Product Code: MBH
• UDI-Device Identifier: 07613327288353
• UDI-Public: 07613327288353
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2025

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 Catalogue Number: 5537-G-509-E
• Device Lot Number: P614LN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female