MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT NO 7 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531-G-716-E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Additional 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 lot referenced.Device evaluation is under review.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, left knee.It was reported that when the inner blister was opened, one side of the locking wire was detached/sitting up from the insert.Rep was present for an witness to the event.A second implant was obtained and the procedure was completed successfully with a delay of approximately 1 minute.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a triathlon insert was reported.The event was confirmed via inspection of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the locking wire is disassociated.The device was further reviewed by the global quality & operations (gqo) team which indicated the following: "on the manufacturing router, locking wire lot 012501x1 was recorded, see the attached router.With documented evidence of a locking wire having been assembled it can confidently be stated that a locking wire was assembled and inspected during the manufacturing and assembly of assembly number 5531-g-716-e, triathlon cs x3 tibial insert lot number mw7xm0 within the tibial plastics cell at stryker mahwah, nj." 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 the locking wire was observed to be separated from the insert upon opening the device packaging during surgery.Visual inspection of the returned device indicated that the locking wire is disassociated.The device was further reviewed by the global quality & operations (gqo) team which indicated the following: "on the manufacturing router, locking wire lot 012501x1 was recorded.With documented evidence of a locking wire having been assembled it can confidently be stated that a locking wire was assembled and inspected during the manufacturing and assembly of assembly number 5531-g-716-e, triathlon cs x3 tibial insert lot number mw7xm0 within the tibial plastics cell at stryker mahwah, nj." the gqo team also performed a review of the dhr and indicated that based on the dhr record review, it can be concluded that all packaging manufacturing steps were performed according to the applicable procedures with no discrepancies related to the locking wire presence and that the sealed package left stryker mahwah with no issues.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.
Event or Problem Description
Primary procedure, left knee.It was reported that when the inner blister was opened, one side of the locking wire was detached/ sitting up from the insert.Rep was present for an witness to the event.A second implant was obtained and the procedure was completed successfully with a delay of approximately 1 minute.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: X3 TRIATHLON CS INSERT NO 7 16MM
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20402029
• Report Number: 0002249697-2024-01382
• Device Sequence Number: 17762226
• Product Code: MBH
• UDI-Device Identifier: 07613327337198
• UDI-Public: 07613327337198
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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-716-E
• Device Lot Number: MW7XM0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 90 KG