MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT NO 4 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531-G-409-E
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, left knee.It was reported that immediately after removing the insert from the sterile blister, the locking wire fell off of the insert.The insert did not come in contact with the patient.A second implant was used to complete the surgery successfully with no delay.Rep was present for and witness to this event.Rep confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
Primary procedure, left knee.It was reported that immediately after removing the insert from the sterile blister, the locking wire fell off of the insert.The insert did not come in contact with the patient.A second implant was used to complete the surgery successfully with no delay.Rep was present for and witness to this event.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding disassociation involving a triathlon insert was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the locking wire has separated from the polyethylene tibial insert.The device was further reviewed by the global quality & operations (gqo) team which indicated the following: "with the manufacturing router for assembly number 5531-g-409-e, triathlon cs x3 tibial insert lot number r3031h showing that the locking wire features were properly inspected and signed off on by trained operator(s) and visual evidence under a microscope of the presence of a locking wire it can be said with confidence that the tibial plastics triathlon insert left the tibial plastics manufacturing cell with the locking wire present and appropriately assembled." clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that immediately after removing the insert from the sterile blister, the locking wire fell off of the insert.Visual inspection of the returned device indicated that the locking wire has separated from the polyethylene tibial insert.The device was further reviewed by the global quality & operations (gqo) team which indicated the following: "with the manufacturing router for assembly number 5531-g-409-e, triathlon cs x3 tibial insert lot number r3031h showing that the locking wire features were properly inspected and signed off on by trained operator(s) and visual evidence under a microscope of the presence of a locking wire it can be said with confidence that the tibial plastics triathlon insert left the tibial plastics manufacturing cell with the locking wire present and appropriately assembled." it cannot be confirmed from the information provided that the reported issue resulted from manufacturing.Furthermore, it is possible that the locking wire dislodged during transportation/handling.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: X3 TRIATHLON CS INSERT NO 4 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20199669
• Report Number: 0002249697-2024-01260
• Device Sequence Number: 6879754
• Product Code: MBH
• UDI-Device Identifier: 07613327337150
• UDI-Public: 07613327337150
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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 Catalogue Number: 5531-G-409-E
• Device Lot Number: R3031H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Female