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

Catalog Number	5550-G-319
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	07/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event was reported for the alleged loosening and pain involving an triathlon patella was reported.The event was not confirmed by medical review.Method & results: product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿there is no documented follow-up subsequent to (b)(6) 2018 or evidence of complaints referable to the right knee except the occasional painless "knocking" sensation noted by the patient on (b)(6) 2018 but not noted in the physical examination.Knocking after total knee arthroplasty could relate to patellar tracking or contact with the ts post of the tibial component.It could also be soft tissue related or related to the retained staple in the femoral condyle.There is no evidence that factors associated with implant manufacturing or materials are responsible for this clinical situation or if it still exists.Should additional information become available, this report will be updated.¿ product history review: a review of the product history records could not be performed as the device was not properly identified.Complaint history review: a complaint history review could not be performed as the device was not properly identified.Conclusions: the reported event regarding the alleged loosening and pain was not confirmed nor the root cause determined.As stated in the clinician¿s review, ¿on (b)(6) 2018 an office visit note states, "six months status-post right tkr.Doing quite well.No pain, playing tennis.Feels a knocking in his knee occasionally.X-ray: excellent position, no problems.0° to 125°.Impression: doing well, return one year." for the noted ¿feels a knocking in his knee occasionally¿, the clinician noted, ¿there is no documented follow-up subsequent to (b)(6) 2018 or evidence of complaints referable to the right knee except the occasional painless "knocking" sensation noted by the patient on (b)(6) 2018 but not noted in the physical examination.Knocking after total knee arthroplasty could relate to patellar tracking or contact with the ts post of the tibial component.It could also be soft tissue related or related to the retained staple in the femoral condyle.There is no evidence that factors associated with implant manufacturing or materials are responsible for this clinical situation or if it still exists.Should additional information become available, this report will be updated.¿ device not available.
Event or Problem Description
Patient reported he is experiencing loosening and pain after his right knee surgery.

• 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: 8060113
• Report Number: 0002249697-2018-03693
• Device Sequence Number: 1327092
• Product Code: MBH
• UDI-Device Identifier: 07613327014761
• UDI-Public: 07613327014761
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2018

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: 5550-G-319
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/12/2018
• 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: Other
• Patient Age: 62 YR
• Patient Weight: 78