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

Catalog Number	5530-G-709
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.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.Not yet returned.
Event or Problem Description
Surgeon attempted to impact tibial insert as per usual technique (using correct insert impactor).However, insert would not engage as it should and when the surgeon took the insert out for further inspection, it was noted that the wire had completely detached from the insert.The initial cr insert was replaced with a cs equivalent insert.
Event or Problem Description
Surgeon attempted to impact tibial insert as per usual technique (using correct insert impactor).However, insert would not engage as it should and when the surgeon took the insert out for further inspection, it was noted that the wire had completely detached from the insert.The initial cr insert was replaced with a cs equivalent insert.
Additional Manufacturer Narrative
An event regarding a seating/locking issue involving triathlon insert was reported.The event was not confirmed.Conclusion: one insert with the locking wire removed was returned for evaluation.There are scratches on the superior surface of the insert consistent with attempted implantation and explantation damage.There is a scratch on the anterior surface of the insert, the locking wire was returned bent.There is also damage to the superior posterior tab of the insert.The event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as images of the device taken when the alleged event was identified is required to complete the investigation for confirming the event and determining a root cause.No further investigation for this event is possible at this time as no device was received by stryker orthopaedics.If the device becomes available, this investigation 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
• MDR Report Key: 7365291
• Report Number: 0002249697-2018-00862
• Device Sequence Number: 1963620
• Product Code: MBH
• UDI-Device Identifier: 07613327046274
• UDI-Public: 07613327046274
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

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: 04/30/2022
• Device Catalogue Number: 5530-G-709
• Device Lot Number: LFT220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 06/12/2018
• 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: 68 YR