MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON KNEE WITH METAL BACKED SYMMETRIC PATELLA; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/30/2020

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Insufficient information was provided to determine the specific reasons for the revisions.The report notes that some revisions may have occurred for more than one reason.Reasons for revisions include the following: infection, instability."all other reasons" (osteoarthritis, acquired leg deformities, etc) aseptic loosening pain other mechanical complications periprosthetic fracture (unspecified) "other complications".

Event Description

In an aaos registry program report for knees where triathlon knees using a metal-backed patella, two groups were analyzed: triathlon knees with metal backed asymmetric patella; triathlon knees with metal backed symmetric patella.24 revisions of symmetric patellae were revised for reasons that include the following (the report notes that some revisions may have occurred for more than one reason): infection, instability."all other reasons" (osteoarthritis, acquired leg deformities, etc) aseptic loosening pain other mechanical complications periprosthetic fracture (unspecified) "other complications".

• Brand Name: UNKNOWN TRIATHLON KNEE WITH METAL BACKED SYMMETRIC PATELLA
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16068751
• MDR Text Key: 306344634
• Report Number: 0002249697-2022-01945
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2022
• Initial Date FDA Received: 12/29/2022
• 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): Required Intervention; Hospitalization