MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #3R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5517-F-302

Device Problem Loss of Osseointegration (2408)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

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.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.

Event Description

Dr.Revised a triathlon pa beaded femoral component size 3 to a cemented size 2 primary cr femur.He also swapped the tibial insert.He did this due to patient stiffness.He said the implant wasn't grossly loose, but noted the distal and posterior interface was mostly fibrous ingrowth.He did note the original x-ray, it looked like the femur may have been flexed slightly relative to the cuts which caused a slight gap in certain areas.Right knee.Update 20/february/2020 wg: rep provided primary and revision usage sheets and reported that no further information will be available.

• Brand Name: TRIATHLON P/A CR BEADED #3R
• 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 ; IE NA
• Manufacturer Contact: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9849333
• MDR Text Key: 188810553
• Report Number: 0002249697-2020-00537
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040951
• UDI-Public: 07613327040951
• 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
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 5517-F-302
• Device Catalogue Number: 5517F302
• Device Lot Number: CR72R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2018
• 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
• Patient Age: 68 YR