MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5536B600

Device Problem Loss of Osseointegration (2408)

Patient Problems Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); Swelling/ Edema (4577)

Event Date 01/08/2024

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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.

Event Description

Patient reported he is a disabled vet.In (b)(6) 2021, had a left knee replacement.Right after implantation, patient had fevers for a week.Patient also experienced swelling, pain, and infections.Patient consulted another doctor in (b)(6) 2023.A bone scan showed loosening (implant not specified but patient was focused on baseplate).Patient was told the baseplate was also recalled.Consulting surgeon referred patient to a specialist who performs revisions.Revision performed (b)(6) 2024.Patient reports he has incurred and is still incurring many medical bills, as well as having had pain and suffering but is in recovery.Patient is seeking compensation and stated he has not yet retained an attorney.

• Brand Name: TRITANIUM BPLATE TRIATHLON S6
• 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 ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18684038
• MDR Text Key: 335074852
• Report Number: 0002249697-2024-00217
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5536B600
• Device Lot Number: CTD56360
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• 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): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 84 KG