MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-309
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon prim tib baseplate - cemented; 5520-b-300 ;kenaa.Unknown_femoral component.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding pain is reported involving triathlon insert.The event was not confirmed.Method & results: product evaluation and results- product inspection - material analysis, functional and dimensional inspections could not be performed as the device was not returned.Visual inspection - the reported device was not returned however photographs were provided for review.The photographs show a recently explanted device with nothing remarkable to report.Clinical review: no medical records were received for review with a clinical consultant.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: an event regarding pain is reported involving triathlon baseplate.The event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information is needed to complete the investigation for determining its root cause.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
It was reported that the patient's right knee was revised due to pain.A size 3 triathlon tibial baseplate, 3 x 9 cs insert, and unknown femoral component were revised.Rep confirmed that other than the explant pictures and revision usage sheet, no further information would be released by the hospital or surgeon.

• Brand Name: X3 TRIATHLON CS INSERT #3 9MM
• 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: 11490347
• Report Number: 0002249697-2021-00453
• Device Sequence Number: 2869528
• Product Code: MBH
• UDI-Device Identifier: 07613327045727
• UDI-Public: 07613327045727
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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: 06/30/2019
• Device Model Number: 5531-G-309
• Device Catalogue Number: 5531G309
• Device Lot Number: LDU968
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/15/2021
• 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: 61 YR
• Patient Weight: 78