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

Model Number	5550-G-319
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Synovitis (2094); Fibrosis (3167)
Date of Event	01/27/2012
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.
Event or Problem Description
This pr was raised from the medical review.The date of the procedure was (b)(6) 2012.In the discharge summary it notes that the patient was having a popping sensation around patella and was admitted for exploration of the joint.She was noted to have extensive synovial hypertrophy and fibrosis around the patella.
Additional Manufacturer Narrative
Reported event an event regarding audible noise involving a triathlon patella was reported.The event was confirmed via clinician review.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted -clinician review: a review of the provided medical information by a clinical consultant indicated: a review of the provided medical records by a clinical consultant indicated: patient underwent primary left total knee arthroplasty in 2010 and another operation in 2012 for peripatellar scarring.She subsequently underwent another surgery for revision due to tibial loosening.I can confirm that the events occurred since i was able to review the operation reports and pre op and post op x-rays.Regarding the possible root cause of this event, i cannot determine this for certain.I don¿t see any abnormality with the implant itself.Tibial loosening is a well-known complication.Operative technique, soft tissue balancing and cementing technique as well as activity level and body habitus are key in the longevity of a total knee replacement.-product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient took an operation for a popping sensation around patella and peripatellar scarring in 2012.The event was confirmed via clinician review based on operation reports and pre op and post op x-rays.The exact cause of the event could not be determined.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
This pr was raised from the medical review.The date of the procedure was (b)(6) 2012.In the discharge summary it notes that the patient was having a popping sensation around patella and was admitted for exploration of the joint.She was noted to have extensive synovial hypertrophy and fibrosis around the patella.

• Brand Name: TRIATHLON SYMMETRIC 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
• MDR Report Key: 12514165
• Report Number: 0002249697-2021-01611
• Device Sequence Number: 1008593
• Product Code: MBH
• UDI-Device Identifier: 07613327014761
• UDI-Public: 07613327014761
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 01/31/2015
• Device Model Number: 5550-G-319
• Device Catalogue Number: 5550-G-319
• Device Lot Number: 0D88
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/20/2021
• 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
• Patient Age: 59 YR