MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CS#4 9MME; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5531-G-409-E

Device Problem Unstable (1667)

Patient Problem Injury (2348)

Event Date 03/02/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Dr.Revised a triathlon tibial insert from a 9mm to a 13mm and added some competitor device medially due to left knee instability in midflexion.Patient bmi 57.Original surgery was (b)(6) 2020.Rep provided primary and revision usage sheets and an x-ray and reported that no further information will be available.

Manufacturer Narrative

An event regarding dislocation involving a triathlon insert was reported.The event was confirmed based on the review of medical record.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as product was not returned -clinician review: a review of the provided medical records rejected by a clinical consultant stated the following comment: x-ray confirms subluxated, dislocated knee, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: it was reported that the patient revised a triathlon tibial insert due to dislocation.The event was confirmed based on the review of medical record.A review of the provided medical records rejected by a clinical consultant stated the following comment: x-ray confirms subluxated, dislocated knee, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Dr.Revised a triathlon tibial insert from a 9mm to a 13mm and added some competitor device medially due to left knee instability in midflexion.Patient bmi 57.Original surgery was (b)(6) 2020.Rep provided primary and revision usage sheets and an x-ray and reported that no further information will be available.

• Brand Name: X3 TRIATHLON INSERT CS#4 9MME
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9898170
• MDR Text Key: 188215265
• Report Number: 0002249697-2020-00632
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327337150
• UDI-Public: 07613327337150
• Combination Product (y/n): N
• PMA/PMN Number: K172634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: 5531-G-409-E
• Device Catalogue Number: 5531G409E
• Device Lot Number: LJL010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 04/17/2020
• Supplement Dates FDA Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR