MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-509
Medical Device Problem Codes	Material Discolored (1170); Fracture (1260); Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
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.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the patient's left knee was revised due to slight instability.The patient's native patella was resurfaced and a poly exchange was performed.It was noticed that the revised insert was discolored where it came into contact with the femoral component (surgeon reported the discoloration as oxidation, no discoloration of any kind noted on the femoral component).Surgeon would like the device investigated to determine the cause of the discoloration, and would like the results.Rep reported the device is allegedly available for return.Rep confirmed he may be able to provide pictures/ usage, and that otherwise, no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's left knee was revised due to slight instability.The patient's native patella was resurfaced and a poly exchange was performed.It was noticed that the revised insert was discolored where it came into contact with the femoral component (surgeon reported the discoloration as oxidation, no discoloration of any kind noted on the femoral component).Surgeon would like the device investigated to determine the cause of the discoloration, and would like the results.Rep reported the device is allegedly available for return.Rep confirmed he may be able to provide pictures/ usage, and that otherwise, no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding instability, wear, and crack/fracture involving a triathlon insert was reported.The wear and crack/fracture events were confirmed by evaluation of the returned device.Instability was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device is discolored yellow in the area upon which the femoral condyles interact.The metal retaining wire is bent and there appears to be some wear damage in the polyethylene.Material analysis: a material analysis was performed and indicated the following: "the uhmwpe x3 tibial insert indicated abrasion wear-related material removal on both the medial and lateral sides where the femoral implant contacts the liner.The wear was greater on one side leaving the liner thinner on one side, raising the stress on it.The fracture on that side is consistent with stress overloads from normal use.It appears that yellow-tinted synovial fluid from the knee joint stained the returned device without degrading of damaging it.Both the polymer liner and the retaining wire showed no signs of material nonconformances nor manufacturing defects on any of the surfaces inspected here." -clinician review: a review of the provided medical information by a clinical consultant indicated: "this inquiry reports the failure of a total knee replacement about 2 years after implantation due to instability.Discoloration of the poly was noted.I cannot confirm that this event took place since i was not able to view any supporting documents such as office notes, hospital notes, explant photos or operation reports.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of instability are multifactorial including surgical technique factors, patient factors, activity level, bmi, and trauma.Causes of discoloration of polyethylene would have to be determined by scientific analysis." -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.Intraoperatively, yellow discoloration of the insert was observed.Visual inspection of the returned device indicated that the device is discolored yellow in the area upon which the femoral condyles interact.The metal retaining wire is bent and there appears to be some wear damage in the polyethylene.A material analysis was performed and indicated the following: "the uhmwpe x3 tibial insert indicated abrasion wear-related material removal on both the medial and lateral sides where the femoral implant contacts the liner.The wear was greater on one side leaving the liner thinner on one side, raising the stress on it.The fracture on that side is consistent with stress overloads from normal use.It appears that yellow-tinted synovial fluid from the knee joint stained the returned device without degrading of damaging it.Both the polymer liner and the retaining wire showed no signs of material nonconformances nor manufacturing defects on any of the surfaces inspected here." a review of the provided x-ray images by a clinical consultant was unable to confirm the reported instability.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: X3 TRIATHLON CS INSERT #5 9MM
• 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: 12623642
• Report Number: 0002249697-2021-01700
• Device Sequence Number: 11892760
• Product Code: MBH
• UDI-Device Identifier: 07613327045871
• UDI-Public: 07613327045871
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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: 05/31/2024
• Device Model Number: 5531-G-509
• Device Catalogue Number: 5531G509
• Device Lot Number: LJF154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2019
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 74 KG