MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR BASEPLATE #3 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 5620-B-301

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Revision of left knee.Stryker uni-knee to total knee.Rep stated that this revision might be due to "lateral side wear." rep could not confirm if the wear is specific to the insert.

Event Description

Revision of left knee.Stryker uni-knee to total knee.Rep stated that this revision might be due to "lateral side wear." rep could not confirm if the wear is specific to the insert.

Manufacturer Narrative

Correction: update to catalog and lot #'s.An event regarding alleged wear involving a triathlon femoral component was reported.The event was not confirmed.Method & results: visual inspection: as per the attached pictures, triathlon femoral component seems to be slightly scratched.Material analysis report : scratching consistent with in-service use was observed on the femoral component.Bone cement was observed on the proximal surface of the implant.X-ray fluorescence spectroscopy analysis was performed on the base material.Elemental constituents of the base material included co, cr, and mo consistent with an astm f75 alloy per the drawing.Based on the given information, no material or manufacturing discrepancies were observed on the surfaces examined.Dimensional inspection and functional inspection could not be done because product is received in damage condition.Complaint history review: lot id: there have been no other events for the lot referenced.Product history review: review of the product history records indicate all devices were manufactured and accepted into final stock with no reported relevant discrepancies.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.No further investigation for this event is possible at this time as no devices information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PKR BASEPLATE #3 LM/RL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9226766
• MDR Text Key: 163934245
• Report Number: 0002249697-2019-03605
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K082567
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 5620-B-301
• Device Lot Number: IFIDA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention