MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #4 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F402

Device Problem Loss of Osseointegration (2408)

Patient Problems Ambulation Difficulties (2544); Inadequate Osseointegration (2646)

Event Date 08/30/2023

Event Type  Injury  

Event Description

As reported via medwatch mw5147241: caller stated that he was implanted with a stryker knee implant 2020.The implant was revised 2023 because it was loose and defective.

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.H3 other text : device not returned to the manufacturer.

Event Description

As reported via medwatch mw5147241: caller stated that he was implanted with a stryker knee implant 2020.The implant was revised 2023 because it was loose and defective.Update 26/december/2023: mw5148864 received.No event description was given but information provided indicates a knee insert was implanted in 2020 and revised in 2023.Med review indicated [.] intraoperative positioning did not appear ideal, nor were the cuts on the femoral side.The knee appears to have been left in hyperextension.The posterior aspect of the femoral component appears to be unsupported by bone.I do not see any defects implant itself.

Manufacturer Narrative

Reported event: an event regarding loosening involving a triathlon femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: material analysis, visual, dimensional and functional inspections were not performed as no devices were returned.-clinician review: a review of medical records with a clinical consultant indicated" this product inquiry concerns a gentleman who underwent a primary cemented total knee arthroplasty with a cruciate retaining femoral component and a cs tibial insert.According to the summary the patient developed loosening and the patient claims it was defective.I can confirm that the patient had the primary total knee arthroplasty since i was able to look at the operation report and intraoperative x-rays.Intraoperative positioning did not appear ideal, nor were the cuts on the femoral side.The knee appears to have been left in hyperextension.The posterior aspect of the femoral component appears to be unsupported by bone.I do not see any defects implant itself.The root cause of this case of loosening cannot be determined with certainty.However i am concerned about the poor cuts on the femur and the position of the femoral component as well as the fact that the knee was left hyperextended.The causes of loosening are multifactorial and we have no information as to what was loose and what was done on the revision.Causes of early loosening are multifactorial including surgical technique, cementing technique, precision of bone cuts, and restoration of satisfactory kinematics instability.Contributing factors could also be the patient's activity level and bmi.At this point i don't see any defects in the implant itself but there certainly could be issues with the surgical technique of implantation [.]" -device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: a review of medical records with a clinical consultant indicated" this product inquiry concerns a gentleman who underwent a primary cemented total knee arthroplasty with a cruciate retaining femoral component and a cs tibial insert.According to the summary the patient developed loosening and the patient claims it was defective.I can confirm that the patient had the primary total knee arthroplasty since i was able to look at the operation report and intraoperative x-rays.Intraoperative positioning did not appear ideal, nor were the cuts on the femoral side.The knee appears to have been left in hyperextension.The posterior aspect of the femoral component appears to be unsupported by bone.I do not see any defects implant itself.The root cause of this case of loosening cannot be determined with certainty.However i am concerned about the poor cuts on the femur and the position of the femoral component as well as the fact that the knee was left hyperextended.The causes of loosening are multifactorial and we have no information as to what was loose and what was done on the revision.Causes of early loosening are multifactorial including surgical technique, cementing technique, precision of bone cuts, and restoration of satisfactory kinematics instability.Contributing factors could also be the patient's activity level and bmi.At this point i don't see any defects in the implant itself but there certainly could be issues with the surgical technique of implantation [.]"the event was confirmed via evaluation of medical records by a clinical consultant.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CR FEM COMP #4 R-CEM
• Type of Device: 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18214503
• MDR Text Key: 329064142
• Report Number: 0002249697-2023-01463
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040289
• UDI-Public: 07613327040289
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 5510F402
• Device Lot Number: BYJ6D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 01/27/2024
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male