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

Catalog Number	5532-G-511-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	07/14/2023
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
During triathlon ps tkr surgery, triathlon x3 tibial bearing insert- ps insert was to be implanted.The stainless steel wire placed on the anterior/ front side of the triathlon x3 ps insert came out while implanting and the insert was no longer usable.There was another triathlon ps insert for back up so that was used and the surgery was completed successfully.
Event or Problem Description
During triathlon ps tkr surgery, triathlon x3 tibial bearing insert- ps insert was to be implanted.The stainless steel wire placed on the anterior/ front side of the triathlon x3 ps insert came out while implanting and the insert was no longer usable.There was another triathlon ps insert for back up so that was used and the surgery was completed successfully.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a triathlon insert was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection of the provided photograph shows an insert with a disassociated locking wire.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: visual inspection of the provided photograph shows an insert with a disassociated locking wire.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 PS 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: 17422280
• Report Number: 0002249697-2023-00854
• Device Sequence Number: 6054732
• Product Code: MBH
• UDI-Device Identifier: 07613327337624
• UDI-Public: 07613327337624
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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 Catalogue Number: 5532-G-511-E
• Device Lot Number: 6M263D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• 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