MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON MB PATELLA PA A35; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5554L350
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	09/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Additional devices listed in this event: catalog: 5530-g-513 description: triathlon cr x3 tibial insert lot: mhka64 ; catalog: 5526b500 description: triathlon prim bead pa sze5 bp lot: sp6ds1 ; catalog: 5517f502 description: triathlon p/a cr beaded #5r lot: splal.At this time, it cannot be determined which, if any of the reported devices may have caused or contributed to the patient's experience.Not returned to the manufacturer.
Event or Problem Description
It was reported that patient's right knee was revised due to pain in anterior knee.A patellar implant and insert were revised.
Additional Manufacturer Narrative
An event regarding pain involving a triathlon patella was reported.On review of the provided photo damage of the patella was confirmed.Pain was not confirmed.The device was not returned however a photo was provided which noted damage to the poly component of the patella.The device was otherwise unremarkable.A review of the provided medical records by a clinical consultant was rejected stating need revision reports, histopathology reports, examination of the explanted components, serial x-rays, and office/clinical notes.The photograph suggested bony ingrowth on the patella and damage to the insert.Review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Review indicated there have been no other similar events for the reported lot.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op xrays, patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
It was reported that patient's right knee was revised due to pain in anterior knee.A patellar implant and insert were revised.

• Brand Name: TRIATHLON MB PATELLA PA A35
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7980940
• Report Number: 0002249697-2018-03433
• Device Sequence Number: 1755962
• Product Code: MBH
• UDI-Device Identifier: 07613327049909
• UDI-Public: 07613327049909
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

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 Expiration Date: 03/30/2013
• Device Catalogue Number: 5554L350
• Device Lot Number: SNK8X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 12/13/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 107