MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON ASYMMETRIC X3 PATELLA; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5551-G-299-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/26/2022
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: triathlon sym cone aug sz c; cat# 5549-a-130; lot# ghxg1.Duracon s-1 10mm full wedge; cat# 6630-6-510 ; lot# hzt4ya.Med howmedica bone plug 1pk; cat# 6215-5-011; lot# cppaaf03bg.Med howmedica bone plug 1pk; cat# 6215-5-011; lot# cppaaf11ba.Tri cemented stem 12mmx50mm; cat# 5560-s-112; lot# 1129689a.Osteonics univ.Distal spacer; cat# 1067-0016; lot# xv5e6e.Mrhk tib ins 10mm xs/s s1/s2; cat# 64813210; lot# llj399.Mrh tib rot comp xs-xl; cat# 64812100; lot# 186012a.Mrhk tibial sleeve; cat# 64812140; lot# llb219.Gmrs small femoral bushing; cat# 64952105; lot# lky637.Mrh tibial b/plt keel sml 1; cat# 64813110; lot# pxy6d.Gmrs small femoral bushing; cat# 64952105; lot# lky637.Gmrs dist fem comp std r 65mm; cat# 64812130; lot# llj768.Gmrs small axle; cat# 64952115; lot# ctd62982.Mrs fem stem w/0 body 15x127mm; cat# 64853115; lot# 243813c.Gmrs dist fem comp sml r 65mm; cat# 64952020; lot# nx37n.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
The following was reported: revision of the patient's right knee on the (b)(6) 2022 due to infection.

• Brand Name: TRIATHLON ASYMMETRIC X3 PATELLA
• 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: 15824595
• Report Number: 0002249697-2022-01669
• Device Sequence Number: 17677999
• Product Code: MBH
• UDI-Device Identifier: 07613327314656
• UDI-Public: 07613327314656
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2022

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 Model Number: 5551-G-299-E
• Device Catalogue Number: 5551-G-299-E
• Device Lot Number: JRND
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Female