MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #6 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5510F601
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
The surgeon reported that when he opened the tibial base plate and femoral component, both items were discolored and did not have the usual high polished appearance.The surgeon used alternative devices to complete the case.
Additional Manufacturer Narrative
An event regarding appearance/darkening on the blasted surface of the device involving a triathlon femoral was reported.The event was confirmed base on visual inspection of the returned component.Conclusion: visual inspection on the returned femoral component confirmed the reported event.There are areas on the blasted surface of the femoral that have a slightly darker smudged appearance than the rest of the surface.Material analysis/characterisation of the areas of discolouration was performed on the returned devices.The characterisation report concludes: characterisation using stereo microscopy and electron microscopy confirmed staining on triathlon baseplate and triathlon femoral.The staining on the triathlon baseplate was identified as cosmetic with carbon observed to be elevated in the stained areas[.] due to the location of the staining on the triathlon femoral, characterisation of the staining using the electron microscopy was not possible i.E.The surface of the part could not be brought to the required working distance to get an eds signal for characterisation.A review of the device history record to detail the device paths through the manufacturing process for the reported baseplate and femoral components was performed which concluded that the baseplate and femoral components were processed through difference finishing lines and were processed though cleaning and packaging a number of weeks apart, therefore there is no apparent commonality in terms of manufacturing, cleaning and packing that may contribute to the "darkening" observed on the blasted surface of the two returned components.No discrepancies, rework or scrap components were recorded for either batch for issues relating to the surface/appearance of the components.There are no other similar reported customer complaints for either lot.The returned baseplate and femoral components were both opened in preparation for use in theatre during a surgery which is a commonality in terms of handling that may have contributed to the "darkening" observed on the blasted surface of the two returned components.The exact cause of the event could not be determined as it is not possible to determine the source of the identified carbon on the returned components.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
The surgeon reported that when he opened the tibial base plate and femoral component, both items were discolored and did not have the usual high polished appearance.The surgeon used alternative devices to complete the case.

• Brand Name: TRIATHLON CR FEM COMP #6 L-CEM
• 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: 7965578
• Report Number: 0002249697-2018-03322
• Device Sequence Number: 1433560
• Product Code: MBH
• UDI-Device Identifier: 07613327040319
• UDI-Public: 07613327040319
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 12/26/2018

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: 04/30/2021
• Device Catalogue Number: 5510F601
• Device Lot Number: AXP3E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 12/26/2018
• 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