MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5515-F-502
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock on with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
As reported: "when implant opened there was a foreign body found in the screw hole of posterior femoral condyle of component".Operative side is right.
Additional Manufacturer Narrative
An event regarding foreign matter involving a triathlon femoral component was reported.The event was confirmed by material analysis report.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the reported event of ¿when implant opened there was a foreign body found in the screw hole of the posterior femoral condyle of the component¿ was confirmed.The foreign material was returned with the device and packaging.Materials analysis tested the returned foreign material but was unable to determine the exact match of the material but noted it contained polyester and polyether urethane.It was determined when reviewing the triathlon femoral cell process which included buffing wheels, fiber wheels, kimwipes, and gloves, it was found that the 250 aegis kvs4 glove used within the cell is made of similar materials.An nc was opened on 28-mar-2018 to address the complaint of foreign material in the screw hole of the posterior femoral condyle of the triathlon femoral component.While gloves used in the manufacturing process were identified as a possible source of the foreign matter, it cannot be confirmed that this is the true root cause.Further, this issue was not found to be systemic or recurring.
Event or Problem Description
As reported: "when implant opened there was a foreign body found in the screw hole of posterior femoral condyle of component".Operative side is right.

• Brand Name: TRIATHLON PS FEM COMPONENT, CEMENTED
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7454583
• Report Number: 0002249697-2018-01219
• Device Sequence Number: 931474
• Product Code: MBH
• UDI-Device Identifier: 07613327050400
• UDI-Public: 07613327050400
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 5515-F-502
• Device Lot Number: BGR7IA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Weight: 107