MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number 5530-G-409

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested and if received will be provided in a supplemental report.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Not returned.

Event Description

I got a triathlon x3 tibial bearing insert cr size 4 9mm off the rack in theatre and noticed there was a brown/orange mark on the outside of the cardboard box (but under the external plastic box wrap).When the scout nurse took the implant out of the cardboard box i inspected the inside of the cardboard box.There were no markings.The scrub nurse opened the sterile packaging but did not touch the implant.I was not sure that the implant would be sterile so the implant was not implanted and another identical implant was used.

Event Description

I got a triathlon x3 tibial bearing insert cr size 4 9mm off the rack in theatre and noticed there was a brown/orange mark on the outside of the cardboard box (but under the external plastic box wrap).When the scout nurse took the implant out of the cardboard box i inspected the inside of the cardboard box.There were no markings.The scrub nurse opened the sterile packaging but did not touch the implant.I was not sure that the implant would be sterile so the implant was not implanted and another identical implant was used.

Manufacturer Narrative

An event regarding alleged packaging issue involving a triathlon insert was reported.The event was confirmed by visual inspection of received package.Conclusion: it was reported that there was a brown/orange mark on the outside of the cardboard box (but under the external plastic box wrap).Visual inspection of the returned device noted that the cardboard box was returned along with the product label.A brown/orange mark is visible on the cardboard box.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.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7645760
• MDR Text Key: 112592881
• Report Number: 0002249697-2018-01987
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050479
• UDI-Public: 07613327050479
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 5530-G-409
• Device Lot Number: ET39DH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Date Manufacturer Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR