MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5530-G-311-E
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The following was reported: in the process of final knee implantation, we confirmed that there is no the locking wire of the insert component.
Additional Manufacturer Narrative
Reported event: an event regarding appearance involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the locking wire is not present.No obvious damage is visible.The device was further reviewed by the global quality & operations (gqo) team who indicated the following: "further investigation conducted was the examination of the complaint part returned back to stryker under a microscope where evidence of a wires presence was ensured.It was observed that residual scratches stemming from the insertion of the locking wire were present.".Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate the 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 missing from the insert during surgery.Visual inspection of the returned device indicated that the locking wire is not present.No obvious damage is visible.The device was further reviewed by the global quality & operations (gqo) team who indicated the following: "further investigation conducted was the examination of the complaint part returned back to stryker under a microscope where evidence of a wires presence was ensured.It was observed that residual scratches stemming from the insertion of the locking wire were present." the gqo team also performed a review of the dhr and indicated that "the locking wire features were properly inspected and signed off on by trained operator(s)" and that "there were no noted discrepancies or anomalies" in subsequent processing steps.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 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.
Event or Problem Description
The following was reported: in the process of final knee implantation, we confirmed that there is no the locking wire of the insert component.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 16486442
• Report Number: 0002249697-2023-00219
• Device Sequence Number: 14867873
• Product Code: MBH
• UDI-Device Identifier: 07613327382686
• UDI-Public: 07613327382686
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2023

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 Model Number: 5530-G-311-E
• Device Catalogue Number: 5530-G-311-E
• Device Lot Number: TT1HR7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• 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 Sex: Unknown