MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-711-E
Medical Device Problem Codes	Difficult to Insert (1316); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
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.
Event or Problem Description
Mako tka.After all knee implants had been inserted, including a cs polyethylene insert, they began to start closing up.As they were closing up, the surgeon made a comment that he thought the poly looked as if it was sticking out a bit anteriorly but that he thought it was fully seated.He then used a precision saw and began to saw off a portion of the anterior polyethylene insert.
Event or Problem Description
Mako tka.After all knee implants had been inserted, including a cs polyethylene insert, they began to start closing up.As they were closing up, the surgeon made a comment that he thought the poly looked as if it was sticking out a bit anteriorly but that he thought it was fully seated.He then used a precision saw and began to saw off a portion of the anterior polyethylene insert.
Additional Manufacturer Narrative
Reported event: an event regarding an off-label use involving a triathlon insert was reported.Conclusion: it was reported that the surgeon used a precision saw to saw off a portion of the anterior polyethylene insert as he thought the poly insert looked as if it was sticking out a bit anteriorly though he thought it was fully seated.There was no issue noticed on the device itself.Based on the provided information it has been determined that this event is associated with an off-label application.A review of ifu indicated in warnings section that "discard all damaged or mishandled implants".It also indicated in utilization and implantation section that "use the recommended trial components for size determination, trial reduction and range of motion evaluation, thus preserving the integrity of the actual implants and their sterile packaging".No further investigation is required 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 #7 11MM
• 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12708626
• Report Number: 0002249697-2021-01792
• Device Sequence Number: 11822087
• Product Code: MBH
• UDI-Device Identifier: 07613327337075
• UDI-Public: 07613327337075
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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: 10/31/2025
• Device Model Number: 5531-G-711-E
• Device Catalogue Number: 5531-G-711-E
• Device Lot Number: LKJ196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• 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: Male