MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SYMMETRIC X3 PATELLA; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	5550-G-319-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Subluxation (4525)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: mrhk tib ins 16mm xs/s s1/s2;64813216;ljc550.Mrh tibial b/plt keel sml 1;64813110;jce2h.Triathlonctrfemconeaug sz 5l;5549-a-651;kynl.Triathlon sym cone aug sz b;5549-a-120;em82.Tri press-fit stem 13mm x 100mm;5565-s-013;0083060m.Tri press-fit stem 18mm x 100mm;5565-s-018;0081933n.Mrhk fem distal blk 10mm xs;64811200;htx7a.Duracon tib wedge rt flt s1 5mm;6630-6-105;vr4ha.Mrhk tibial sleeve;64812140;ljs502.Mrh tib rot comp xs-xl;64812100;168183.Mrhk fem distal blk 10mm xs;64811200;ee72e.Duracon tib wedge lt flt s1 5mm;6630-6-125;bd74za.Mrh axle;64812120;unknown.Mrhk femoral bushing;64812110;lja144.Mrhk bumper insert 3 degrees;64812133;ljm743.Mrhk femoral bushing;64812110;ljl20.7.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding infection and dislocation involving a triathlon patella was reported.The event was not confirmed.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
This pi is for the (b)(6) 2020 revision.Patient underwent primary tka outside of cors scope.Had a revision tka on (b)(6) 2020 for pji.Patient had a fall plus subluxation of the patella, she also had symptoms of reinfection of the left knee.A revision was performed on (b)(6) 2020, a periprosthetic fracture b1 of the femur was observed, and maltracking of the patella.All components were exchanged except the tibial stem.

• Brand Name: TRIATHLON SYMMETRIC X3 PATELLA
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11375109
• Report Number: 0002249697-2021-00343
• Device Sequence Number: 14396370
• Product Code: JWH
• UDI-Device Identifier: 07613327314779
• UDI-Public: 07613327314779
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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: 05/31/2024
• Device Model Number: 5550-G-319-E
• Device Catalogue Number: 5550-G-319-E
• Device Lot Number: RYA8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/24/2021
• 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: 62 YR
• Patient Weight: 98