MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G509

Device Problems Break (1069); Fracture (1260); Scratched Material (3020)

Patient Problem Injury (2348)

Event Date 01/15/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

Inlay was dorsal broken.

Event Description

Inlay was dorsal broken.

Manufacturer Narrative

An event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed based on the returned insert.Conclusion: visual inspection confirmed that the explanted insert component was returned damaged, with material loss in one of the posterior compartments on the articulating surface.Material analysis concluded: [.] a localized area of material loss was observed along the articulating surface; posterior edge, likely resulting from the cyclic edge loading of the femoral component.There was no evidence of manufacturing or material defects on the returned ultra-high molecular weight polyethylene (uhmwpe) tibial insert.The cause of the event cannot be determined as insufficient information was provided.Further information such as x-rays and medical records are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: X3 TRIATHLON CS INSERT #5 9MM
• 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: 7266956
• MDR Text Key: 99924895
• Report Number: 0002249697-2018-00399
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• 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: 03/26/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 5531G509
• Device Lot Number: LEK377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 02/26/2018
• Supplement Dates FDA Received: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention