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

Model Number	5550-G-278
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	08/09/2016
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 has been similar events for the lot referenced however, it is related to the same patient.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
This pr was raised from a medical review for another event.The patient had left knee arthroplasty on (b)(6) 2011.A quad repair was carried out six months post implantation.Revision surgery took place on (b)(6) 2012 due to instability whereby the insert was revised.Revision surgery took place on (b)(6) 2016 due to subsidence and instability whereby all components were revised.
Additional Manufacturer Narrative
An event regarding subsidence and instability involving triathlon patella was reported.  conclusion:  based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
This pr was raised from a medical review for another event.The patient had left knee arthroplasty on (b)(6) 2011.A quad repair was carried out six months post implantation.Revision surgery took place on (b)(6) 2012 due to instability whereby the insert was revised.Revision surgery took place on (b)(6) 2016 due to subsidence and instability whereby all components were revised.

• 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: 12496950
• Report Number: 0002249697-2021-01576
• Device Sequence Number: 11739389
• Product Code: MBH
• UDI-Device Identifier: 07613327014730
• UDI-Public: 07613327014730
• 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: 2011
• Device Explanted Year: 2016
• 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: 05/31/2016
• Device Model Number: 5550-G-278
• Device Catalogue Number: 5550-G-278
• Device Lot Number: J4AW
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/20/2021
• 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; Required Intervention
• Patient Age: 57 YR