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-609-E
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During poly impaction surgeon could not lock the poly triathlon mechanism into the tibia.The poly was removed and inspected and impacted again.At second attempt poly appeared seated and locked.Post op x-ray showed issue with locking mechanism.
Additional Manufacturer Narrative
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.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 not returned.
Event or Problem Description
During poly impaction surgeon could not lock the poly triathlon mechanism into the tibia.The poly was removed and inspected and impacted again.At second attempt poly appeared seated and locked.Post op x-ray showed issue with locking mechanism.
Additional Manufacturer Narrative
Reported event an event regarding seating/locking issues involving a triathlon insert was reported.The event was confirmed through clinician review of the provided x-rays.Method & results product evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: on the ap x-rays of the right tka the locking wire of the tibial insert is seen to be displaced from its native position.The failure to properly seat the tibial insert with disruption of the locking mechanism is confirmed.The root cause of this failure can not be determined from this limited information.Should further documentation become available i would be happy to further this assessment.Device 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 reported lot.Conclusion: the event reported during poly impaction surgeon could not lock the poly triathlon mechanism into the tibia.A review of the provided medical records by a clinical consultant stated the following comment: on the ap x-rays of the right tka the locking wire of the tibial insert is seen to be displaced from its native position.The failure to properly seat the tibial insert with disruption of the locking mechanism is confirmed.The root cause of this failure can not be determined from this limited information further information such as video/photographs of the event as it occurred as well as return of the device and primary operative reports are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12827842
• Report Number: 0002249697-2021-01920
• Device Sequence Number: 13823398
• Product Code: MBH
• UDI-Device Identifier: 07613327383133
• UDI-Public: 07613327383133
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: 06/30/2026
• Device Model Number: 5530-G-609-E
• Device Catalogue Number: 5530-G-609-E
• Device Lot Number: RA4PTK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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 Age: 74 YR
• Patient Sex: Male