MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G513

Device Problems Material Discolored (1170); Unstable (1667)

Patient Problems Hematoma (1884); Swelling (2091); Injury (2348)

Event Date 11/21/2018

Event Type  Injury  

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.Device not returned.

Event Description

Sent to sem and investigate the yellow coloring components.Implanted trn-tka.Acl-incompetent knee, absence of internal and external cartilage, oa, hyperextended knee.After several weeks, swelling, instability and hematoma were observed, so the synovectomy was performed.Suspected infection, but it was decided an infection negative based on investigation.Since hematoma was again observed, synovial resection and insert exchanged.There is no infection.Synovial proliferation was extended down to the insert.The replacement new insert was an increased thickness of 16 mm.

• Brand Name: X3 TRIATHLON CS INSERT #5 13MM
• 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: anna smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8181290
• MDR Text Key: 130911208
• Report Number: 0002249697-2018-04084
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327045888
• UDI-Public: 07613327045888
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5531G513
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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