MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5530-G-513
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
During a triathlon total knee procedure, after implantation on the final prosthesis, the poly thickness needed to be increased.The initial poly was removed and another inserted.The poly was unable to be locked into the base plate and was down laterally but raised medially.After several attempts to seat the poly it had to be removed and another implanted.This time successfully.
Additional Manufacturer Narrative
An event regarding a seating/locking issue involving a triathlon insert was reported.The event was not confirmed.Conclusion: one insert component with the locking wire attached with the lot number 3740vr was returned for evaluation.The locking wire is bent and out of the locking wire tab on one side.Damage is visible on the inferior posterior side of the insert as well as the anterior superior side.There are also scratches visible on the inferior and side of the insert.Damage is consistent with attempted implantation and subsequent explantation of the device.The event itself could not be confirmed as 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 is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
During a triathlon total knee procedure, after implantation on the final prosthesis, the poly thickness needed to be increased.The initial poly was removed and another inserted.The poly was unable to be locked into the base plate and was down laterally but raised medially.After several attempts to seat the poly it had to be removed and another implanted.This time successfully.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7718685
• Report Number: 0002249697-2018-02298
• Device Sequence Number: 1065871
• Product Code: MBH
• UDI-Device Identifier: 07613327050547
• UDI-Public: 07613327050547
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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: 08/30/2022
• Device Catalogue Number: 5530-G-513
• Device Lot Number: 3740VR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 09/19/2018
• 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: 63 YR
• Patient Weight: 79