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
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 0002249697-2018-01987
• Device Sequence Number: 13739686
• Product Code: MBH
• UDI-Device Identifier: 07613327050479
• UDI-Public: 07613327050479
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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: 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
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 09/24/2018
• 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: 70 YR