MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G413
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding revision involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot.Conclusions: it was reported that the patient was experiencing patella pain related to non resurfacing and during revision the patella was resurfaced and insert was changed.The event could not be confirmed nor the cause be determined as insufficient information was available.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Device not returned.
Event or Problem Description
This pi is for the liner exchange and patella resurfacing on (b)(6) 2019.Surgeon reports patient status post left total knee done on (b)(6) 2015 and a subsequent distal femur fracture on the left side which appeared to be fixed with an orif plate has had some patella pain related to non-resurfacing.Dr decided to resurface the patella and change the insert to a thicker size.Surgery was performed without incident.No further information is available due to password secured emr.

• Brand Name: X3 TRIATHLON CS INS SIZE4 13MM
• 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: 8518509
• Report Number: 0002249697-2019-01624
• Device Sequence Number: 1474381
• Product Code: MBH
• UDI-Device Identifier: 07613327045819
• UDI-Public: 07613327045819
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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: 11/30/2019
• Device Catalogue Number: 5531G413
• Device Lot Number: LEB004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/16/2019
• 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: 71 YR