MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-709-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	06/10/2021
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
It was reported that during a primary knee procedure, when the insert was removed during the packaging, the surgeon noted the locking wire was disengaged from the polyethylene.The device was removed from the field without contact the patient.A second device was used to complete the surgery with no delay.A rep was present for and witnessed the event.The usage sheet with the wasted device noted and pictures were provided.Rep confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that during a primary knee procedure, when the insert was removed during the packaging, the surgeon noted the locking wire was disengaged from the polyethylene.The device was removed from the field without contact the patient.A second device was used to complete the surgery with no delay.A rep was present for and witnessed the event.The usage sheet with the wasted device noted and pictures were provided.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 photographs.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: photos show the device with biological material throughout.Device condition could not be determined via photos provided.The locking wire was shown to be attached to the insert but not fully seated confirming the reported disassociation event.-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: the reported device was not returned however photographs were provided for review.The photographs note the following: photos show the device with biological material throughout.Device condition could not be determined via photos provided.The locking wire was shown to be attached to the insert but not fully seated confirming the reported disassociation event.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.

• Brand Name: X3 TRIATHLON CS INSERT #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
• MDR Report Key: 12116175
• Report Number: 0002249697-2021-01130
• Device Sequence Number: 3362160
• Product Code: MBH
• UDI-Device Identifier: 07613327337464
• UDI-Public: 07613327337464
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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: 03/31/2026
• Device Model Number: 5531-G-709-E
• Device Catalogue Number: 5531-G-709-E
• Device Lot Number: A38WLE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 07/05/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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: 63 YR