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-509
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Revision of insert due to instability.
Event or Problem Description
Revision of insert due to instability.
Additional Manufacturer Narrative
Reported event; an event regarding instability involving a triathlon insert was reported.The event was not confirmed.Method & results: -device evaluation and results: the insert without its locking wire was returned for evaluation.Discoloration and damage consistent with in vivo use and explantation process is visible on the device.Examination by engineer indicated common damage modes of uhmwpe present on the returned device.Explantation damage was also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: no medical records were received for review with a clinical consultant.-device history review: all 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 could not be confirmed as insufficient information was provided.Further information such as return of the device, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes 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.
Event or Problem Description
Revision of insert due to instability.
Additional Manufacturer Narrative
Reported event; an event regarding instability involving a triathlon insert was reported.The event of instability was not confirmed, while the event of wear was confirmed via evaluation of the returned device.Method & results: -device evaluation and results: the insert without its locking wire was returned for evaluation.Discoloration and damage consistent with in vivo use and explantation process is visible on the device.Examination by engineer indicated common damage modes of uhmwpe present on the returned device.Explantation damage was also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: a review of the provided medical records by a clinical consultant indicated: confirmation: a revision surgery cannot be confirmed without additional medical records.That said, a polyethylene tibial insert was provided with significant wear posteriorly and this would match/explain the findings on an x-ray provided.Root cause: if the revision were confirmed and the polyethylene in the photos was from the x-rays presented, the root cause of the revision would be polyethylene wear/failure posteriorly.This could certainly explain a finding of instability.The reason for the marked poly wear cannot be determined without additional materials.-device history review: all 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: it was reported that the patient's knee was revised due to instability.The insert without its locking wire was returned for evaluation.Discoloration and damage consistent with in vivo use and explantation process is visible on the device.Examination by engineer indicated common damage modes of uhmwpe present on the returned device.Explantation damage was also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review indicates that a polyethylene tibial insert was provided with significant wear posteriorly and this would match/explain the findings on an x-ray provided.The exact cause of the event could not be determined.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-LIMERICK; raheen business park; limerick NJ NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12002685
• Report Number: 0002249697-2021-01035
• Device Sequence Number: 11659901
• Product Code: MBH
• UDI-Device Identifier: 07613327050530
• UDI-Public: 07613327050530
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2021

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 Expiration Date: 09/30/2020
• Device Model Number: 5530-G-509
• Device Catalogue Number: 5530-G-509
• Device Lot Number: 2855T1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 08/12/2021; 11/29/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 09/02/2021; 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2015
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 64 KG