MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE 4 9MM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number 5531G409

Device Problems Break (1069); Fracture (1260); Material Deformation (2976)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 05/18/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Sales rep reported a left knee primary revision surgery, surgeon did a poly swap due to fracture.The point loading on the medial posterior rim broke, possible rotation issue and the way the patient walks.

Manufacturer Narrative

An event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed.Method & results: device evaluation and results: a material analysis concluded: 'delamination, burnishing, scratching and third-body indentation were observed on the insert condyles.These are common damage modes of uhmwpe.Explantation damage and wear impression markings were also observed on the insert.No material or manufacturing defects were observed on the surfaces examined'.There is also evidence of posterior edge loading of the femoral component on to the tibial insert.Medical records received and evaluation: not performed as medical records were not provided.Device history review: indicates 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: the material analysis report indicated that delamination, burnishing, scratching and third-body indentation were observed on the insert condyles.These are common damage modes of uhmwpe.Explantation damage and wear impression markings were also observed on the insert.No material or manufacturing defects were observed on the surfaces examined.There is also evidence of posterior edge loading of the femoral component on to the tibial insert which may have contributed to the fracture of the posterior aspect of the tibial insert.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Sales rep reported a left knee primary revision surgery, surgeon did a poly swap due to fracture.The point loading on the medial posterior rim broke, possible rotation issue and the way the patient walks.

• Brand Name: X3 TRIATHLON CS INS SIZE 4 9MM
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NJ NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6646571
• MDR Text Key: 77732655
• Report Number: 0002249697-2017-01905
• 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: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2018
• Device Catalogue Number: 5531G409
• Device Lot Number: LDG562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2013
• 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): Other; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 104