MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CR#7 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530G711

Device Problems Mechanical Problem (1384); Unstable (1667); Device Operates Differently Than Expected (2913); Physical Property Issue (3008); Unintended Movement (3026)

Patient Problems Fall (1848); Failure of Implant (1924); Damage to Ligament(s) (1952); Injury (2348)

Event Date 02/03/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

It was reported that the patient fell and knee popped.Doctor scheduled for revision, liner swap, mcl repair.

Manufacturer Narrative

An event regarding instability involving a triathlon insert was reported.The event was confirmed through medical records.Method & results: -device evaluation and results: the device was not returned.However an image of the insert was provided.There were damage and wear observed on the posterior side with blood stains.-medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated that x-ray confirms subluxation and instability; but deemed the information insufficient and rejected it for a medical review.Device 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 reported lot.Conclusions: an image of the insert was provided, damage and wear observed on the posterior side with blood stains.Clinician review of the records provided indicated that x-ray confirms subluxation and instability but could not determined the root cause.Further information such as patient history, histopathology report, examination of explanted components & follow-up notes are needed to investigate this event further.A capa trend analysis was conducted for the reported failure mode and concluded instability may result from other factors not necessarily related to the device.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

It was reported that the patient fell and knee popped.Doctor scheduled for revision, liner swap, mcl repair.

• Brand Name: X3 TRIATHLON INSERT CR#7 11MM
• Type of Device: 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
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6371994
• MDR Text Key: 68814901
• Report Number: 0002249697-2017-00754
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2011
• Device Catalogue Number: 5530G711
• Device Lot Number: 9LNMMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 104