MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT NO 7 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531-G-709-E
Medical Device Problem Codes	Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.H3 other text : not returned.
Event or Problem Description
Primary procedure, left knee.It was reported that the insert was not seating posteriorly.Insert was wasted and a second insert obtained.This insert was also not seating posteriorly.The insert had to be held in place and gently malleted in.Procedure completed successfully with a delay of less than one minute.Tourniquet was used.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding seating/locking issues involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.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 on 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 insert was not seating posteriorly during implantation.Insert was wasted and a second insert obtained.This second insert was also not seating posteriorly.The insert had to be held in place and gently malleted in.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device and/or photographs of the reported event are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Primary procedure, left knee.It was reported that the insert was not seating posteriorly.Insert was wasted and a second insert obtained.This insert was also not seating posteriorly.The insert had to be held in place and gently malleted in.Procedure completed successfully with a delay of less than one minute.Tourniquet was used.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: X3 TRIATHLON CS INSERT NO 7 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: 18702763
• Report Number: 0002249697-2024-00226
• Device Sequence Number: 17969364
• Product Code: MBH
• UDI-Device Identifier: 07613327337464
• UDI-Public: 07613327337464
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2024

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 5531-G-709-E
• Device Lot Number: EV7608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2023
• 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