MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5520-B-500
Medical Device Problem Codes	Degraded (1153); Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right knee was revised due to instability (surgeon reported suspicion that a ruptured pcl was the underlying cause).Intra-operatively, it was observed that the insert wore through posteriorly and the femoral component wore against the baseplate, causing metallosis.The entire knee construct was revised to a new triathlon construct with stems and augments.Rep confirmed that no further information will be released by the hospital or surgeon.
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.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.
Event or Problem Description
It was reported that the patient's right knee was revised due to instability (surgeon reported suspicion that a ruptured pcl was the underlying cause).Intra-operatively, it was observed that the insert wore through posteriorly and the femoral component wore against the baseplate, causing metallosis.The entire knee construct was revised to a new triathlon construct with stems and augments.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a triathlon baseplate was reported.It was reported that 'it was observed that the insert wore through posteriorly and the femoral component wore against the baseplate, causing metallosis' however, wear was not identified during visual inspection.Method & results: -product evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted triathlon baseplate with nothing remarkable to report.From the photographs provided there is evidence of biological matter and boney ingrowth on the device.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: 'i have reviewed the documentation for the product inquiry summary, an implant sheet from a revision surgery and a lateral view of a tka.The event description from the product inquiry summary states: it was reported that the patient's right knee was revised due to instability (surgeon reported suspicion that a ruptured pcl was the underlying cause).Intra-operatively, it was observed that the insert wore through posteriorly and the femoral component wore against the baseplate, causing metallosis.The entire knee construct was revised to a new triathlon construct with stems and augments.Rep confirmed that no further information will be released by the hospital or surgeon.On the lateral x-ray the femur is posteriorly subluxed in reference to the tibia demonstrating frank instability.The implant sheet reflects components consistent with a revision surgery.Revision of a primary tka for instability is confirmed.No evidence was presented to document pcl rupture or component wear/damage.The root cause of the tka instability cannot be identified from this limited documentation, should additional information become available i would be happy to further this assessment.' -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 was revised due to instability.The reported device was not returned however photographs were provided for review.The photographs show a recently explanted triathlon femoral component with nothing remarkable to report.From the photographs provided there is evidence of biological matter and boney ingrowth on the device.A review of the provided medical records by a clinical consultant stated the following comment: 'on the lateral x-ray the femur is posteriorly subluxed in reference to the tibia demonstrating frank instability.The implant sheet reflects components consistent with a revision surgery.Revision of a primary tka for instability is confirmed.No evidence was presented to document pcl rupture or component wear/damage.The root cause of the tka instability cannot be identified from this limited documentation' the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #5
• 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 NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16898745
• Report Number: 0002249697-2023-00487
• Device Sequence Number: 20544969
• Product Code: MBH
• UDI-Device Identifier: 07613327041057
• UDI-Public: 07613327041057
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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: 04/30/2017
• Device Model Number: 5520-B-500
• Device Catalogue Number: 5520B500
• Device Lot Number: S9BEJ
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2012
• 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: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 73 KG