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

Model Number	5551-G-320
Medical Device Problem Codes	Fracture (1260); Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Patient stated that his right triathlon knee is "coming apart", primary surgery (b)(6) 2011.States his knee cap is loose and experiences soreness.Primary surgeon stated to him he would "not" do a revision due to his age and heart.Patient sought a second opinion, (b)(6) 2023, dr.Confirmed that his knee cap is loose.Xrays confirm that the knee cap is in "two pieces".He also had a protruding bulge on the knee at the time of the second opinion.Patient stated that since his second opinion in (b)(6) he now has 2-3 knee bulges/lumps that are palpable and protruding however cannot confirm they are actual knee cap "pieces".
Event or Problem Description
Patient stated that his right triathlon knee is "coming apart", primary surgery (b)(6) 2011.States his knee cap is loose and experiences soreness.Primary surgeon stated to him he would "not" do a revision due to his age and heart.Patient sought a second opinion, february 2023, dr.Confirmed that his knee cap is loose.Xrays confirm that the knee cap is in "two pieces".He also had a protruding bulge on the knee at the time of the second opinion.Patient stated that since his second opinion in february he now has 2-3 knee bulges/lumps that are palpable and protruding however cannot confirm they are actual knee cap "pieces".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving triathlon patella was reported.The event was confirmed by medical review.Method & results: -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: conclusion/assessment: an elderly and medically compromised patient with 11 year old cemented triathlon right tka sustained a displaced and comminuted patella fracture.Event confirmation: the patella fracture was confirmed.Root cause: the root cause of the patella fracture was not defined.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : not available.

• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16626578
• Report Number: 0002249697-2023-00319
• Device Sequence Number: 20150734
• Product Code: MBH
• UDI-Device Identifier: 07613327014815
• UDI-Public: 07613327014815
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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: 03/31/2016
• Device Model Number: 5551-G-320
• Device Catalogue Number: 5551-G-320
• Device Lot Number: XK9V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2011
• 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: Other
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White