MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-311
Medical Device Problem Codes	Break (1069); Fracture (1260); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
Insert dislocated posteriorly due to breakage (wear).
Event or Problem Description
Insert dislocated posteriorly due to breakage (wear).
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture/wear and disassociation were reported.The event of crack/fracture/wear was confirmed through visual inspection of the provided photograph, the event of disassociation was not confirmed.Method & results: device evaluation and results: no product was returned for evaluation however, a photograph was provided.The photograph shows a recently explanted insert with blood visible on the device.The insert is broken/cracked.Clinician review: a review of the provided medical records indicated: this inquiry reports the failure of a cruciate retaining total knee replacement at about 10 years post operative.I cannot confirm that this event took place since i was only able to see an explanted polyethylene component.I do not have an operation report or office notes corroborating the failure.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of failure due to polyethylene wear and fracture is multifactorial.Leaving a posterior cruciate ligament too tight in a cruciate retaining total knee causes a cam effect and creates a tight posterior space.This is well known to cause wear and polyethylene failure.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the event of crack/fracture/wear was confirmed through visual inspection of the provided photograph.The event of disassociation was not confirmed.A review of the provided medical records indicated: a review of the provided medical records indicated: this inquiry reports the failure of a cruciate retaining total knee replacement at about 10 years post operative.I cannot confirm that this event took place since i was only able to see an explanted polyethylene component.I do not have an operation report or office notes corroborating the failure.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of failure due to polyethylene wear and fracture is multifactorial.Leaving a posterior cruciate ligament too tight in a cruciate retaining total knee causes a cam effect and creates a tight posterior space.This is well known to cause wear and polyethylene failure.Further information such as lot identification and return of the device, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining 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.

• Brand Name: X3 TRIATHLON CS INSERT #3 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12974797
• Report Number: 0002249697-2021-02036
• Device Sequence Number: 4883828
• Product Code: MBH
• UDI-Device Identifier: 07613327045734
• UDI-Public: 07613327045734
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

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 Model Number: 5531-G-311
• Device Catalogue Number: 5531G311
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 100 KG