MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON REVISION INSERT X3 SZ6 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5612-X-613
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
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
This pi is for the revision of the insert.Patient dislocated his poly.Dr.Reduced it a week or so prior to the revision.Upon removal of the poly significant wear was found on the underside.Dr.Does not believe it to be an implant malfunction but more so on the lack of patient compliance.
Event or Problem Description
This pi is for the revision of the insert.Patient dislocated his poly.Dr.Reduced it a week or so prior to the revision.Upon removal of the poly significant wear was found on the underside.Dr.Does not believe it to be an implant malfunction but more so on the lack of patient compliance.
Additional Manufacturer Narrative
An event regarding disassociation involving a triathlon insert was reported.The event was confirmed via evaluation of the returned device.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned tibial insert and its components indicated that the poly insert received was actually a triathlon ts tibial insert, as noted by the shape of the device as well as the catalog number visible on the underside of the device (catalog engraving: 5537-g-613-e).The tibial insert exhibited significant wear on the underside, as reported, which is indicative of the insert never having fully locked into the baseplate.-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: it was reported that the patient experienced a dislocation and surgeon performed closed reduction.A week following the closed reduction, the patient was revised.During the revision, significant wear was observed on the underside of the tibial insert.Visual inspection of the returned tibial insert and its components indicated that the poly insert received was actually a triathlon ts tibial insert, as noted by the shape of the device as well as the catalog number visible on the underside of the device (catalog engraving: 5537-g-613-e).The tibial insert exhibited significant wear on the underside, as reported, which is indicative of the insert never having fully locked into the baseplate.The triathlon revision baseplate and hinge knee system surgical protocol compendium indicates in the system compatibility chart that the revision baseplate is not compatible with the triathlon ts insert but is compatible with the triathlon revision insert and the triathlon hinge insert.The use of a non-compatible ts insert with the revision baseplate resulted in the inability to properly lock the insert into the baseplate and subsequent wear.The global quality & operations (gqo) bbs and packaging teams reviewed the event and indicated the following: "based on the nature of the complaint, no relevant nc¿s being found, no opened quarantine tickets, the time gap for packaging operation steps for the affected lots, and the fact that the same hospital received both insert units, it has been determined that this is likely a product mix that occurred at the hospital.The global quality and operations investigation process is unable to confirm that this complaint is a manufacturing-related error." based on this information, it is likely that the ts insert and the revision insert were both opened during this surgery and inadvertently swapped, but this cannot be confirmed.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.

• Brand Name: TRIATHLON REVISION INSERT X3 SZ6 13MM
• 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: 20390565
• Report Number: 0002249697-2024-01372
• Device Sequence Number: 12399362
• Product Code: MBH
• UDI-Device Identifier: 07613327560329
• UDI-Public: 07613327560329
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K230416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 5612-X-613
• Device Lot Number: 391Y98
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male