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

Model Number	5532-G-411
Medical Device Problem Codes	Material Discolored (1170); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left knee was revised due to pain.Surgeon performed cyst removal and exchanged a 4x11 ps insert for a 4x12 ps insert.Upon explantation, the insert was seen to have some form of discoloration/ crystallization under the surface of the insert.
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.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's left knee was revised due to pain.Surgeon performed cyst removal and exchanged a 4x11 ps insert for a 4x12 ps insert.Upon explantation, the insert was seen to have some form of discoloration/ crystallization under the surface of the insert.
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection was performed as part of the material analysis: image shows the articulating surface of the triathlon ps x3 tibial insert.Slight yellow discolouration consistent with oxidation, possibly a result of synovial fluid absorption, was observed on the insert.Explantation damage was observed on the distal surface of the insert.Explantation damage was observed on the anterior surface of the insert.Material analysis: a material analysis was performed and concluded the following: "review of triathlon ps x3 tibial insert, catalogue # 5532-g-411, lot code tr6kke confirmed the presence of discolouration.Characterisation using stereo microscopy confirmed discolouration consistent with absorption of synovial fluid.No manufacturing related defects were observed on the device surfaces examined." clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate the 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 pain.It was further reported that the device appeared discolored upon explantation.A material analysis was performed on the returned device and concluded the following: "review of triathlon ps x3 tibial insert, catalogue # 5532-g-411, lot code tr6kke confirmed the presence of discolouration.Characterisation using stereo microscopy confirmed discolouration consistent with absorption of synovial fluid.No manufacturing related defects were observed on the device surfaces examined." the exact cause of the event could not be determined because insufficient information was provided.Further information such as 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 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 13800899
• Report Number: 0002249697-2022-00409
• Device Sequence Number: 4030065
• Product Code: MBH
• UDI-Device Identifier: 07613327050714
• UDI-Public: 07613327050714
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

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: 04/30/2020
• Device Model Number: 5532-G-411
• Device Catalogue Number: 5532-G-411
• Device Lot Number: TR6KKE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2015
• 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: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female