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

Catalog Number	5515-F-301
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Femur size 4 (right) got a shrinkage cavity on the condyle bearing surface.
Event or Problem Description
Femur size 4 (right) got a shrinkage cavity on the condyle bearing surface.
Additional Manufacturer Narrative
An event regarding damage involving a triathlon femoral component was reported.The event was confirmed by product inspection.Conclusion: the device was discovered during inspection at a third party location.A visual inspection was completed by the manufacturing cell.The reported surface defect on the femoral component was confirmed by the manufacturing cell but was deemed not a manufacturing defect as the device would not have passed the visual inspection criteria as per the manufacturing procedures.After further investigation of this device, the origin of the defect could not be confirmed to be manufacturing related.The nature of the defect is not indicative of any manufacturing defects and handling by 3rd parties could have resulted in the creation of the notch.There was no surgical procedure associated with the reported event.No further investigation is required at this time.

• Brand Name: TRIATHLON PS FEM COMPONENT, CEMENTED
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7358465
• Report Number: 0002249697-2018-00814
• Device Sequence Number: 11268624
• Product Code: MBH
• UDI-Device Identifier: 07613327050356
• UDI-Public: 07613327050356
• Combination Product (Y/N): N
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2018

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: 12/31/2022
• Device Catalogue Number: 5515-F-301
• Device Lot Number: A7Y7RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 05/23/2018
• 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