MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520B500

Device Problem Material Discolored (1170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2018

Event Type  malfunction  

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 reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

The surgeon reported that when he opened the tibial base plate and femoral component, both items were discoloured and did not have the usual high polished appearance.The surgeon used alternative devices to complete the case.

Event Description

The surgeon reported that when he opened the tibial base plate and femoral component, both items were discoloured and did not have the usual high polished appearance.The surgeon used alternative devices to complete the case.

Manufacturer Narrative

An event regarding appearance/darkening on the blasted surface of the device involving a triathlon baseplate was reported.The event was confirmed base on visual inspection of the returned component.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: visual inspection on the returned baseplate component confirmed the reported event.There is one small area on the blasted surface on the distal side of the baseplate near the keel and on the intercondylar space on the distal side that has 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.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #5
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7965581
• MDR Text Key: 123818656
• Report Number: 0002249697-2018-03321
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041057
• UDI-Public: 07613327041057
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• 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: 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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 5520B500
• Device Lot Number: ALT2C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 11/28/2018
• Supplement Dates FDA Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other