MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH KX+ DURAT LS INSERT LRG 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	64795315
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Subluxation (4525); Insufficient Information (4580)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: as per pss implant request: 73 yo male w/ pmh notable for peripheral vascular disease c/b extremely poor wound healing potential and afib (s/p permanent pacemaker, on eliquis).Underwent right distal femoral osteotomy procedure in ~1964, and subsequently right distal femur removal of hardware, tka in 2001 (kinemax plus extra-large femur, large tibia, large patella, 15mm polyethylene liner).At present, the patient has worn out his polyethylene liner, resulting in mcl attenuation and anteromedial subluxation, and an extremely unstable knee.Plastic surgery has evaluated the patient due to his poor wound healing potential and believe he has an extremely high chance of a wound healing complication with any surgical insult.To reduce the likelihood of a complication, i'd like to perform a polyethylene liner exchange, as opposed to a complete revision, if possible.The liner exchange would provide knee stability without the soft tissue and bony trauma from an extensive, full component revision, and reduce the likelihood of a complication.Update 06-october-2025 (b)(6): spoke to rep.The surgeon decided not to go with a custom implant for this patient.The rep is not aware if the patient was revised with off-the-shelf components or any competitor devices.The rep is unable to obtain any further information from the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a kinemax insert was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, 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 indicated: 'i can confirm that the patient underwent a right kinemax plus total knee arthroplasty since i was able to see an x-ray with the implant in place.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of polyethylene wear at 24 years after implantation are multifactorial.These causes include surgical technique in the way the implant is positioned and balanced with proper restoration of the kinematics of the knee.Other contributing causes include patient factors such as the patient's activity level, lifestyle and bmi.While polyethylene wear is an implant issue, i could not assign any causality to the implant unless it could be shown that there was some defect in the manufacturing process.Wear of the polyethylene component can be attributed to development of ligamentous laxity with alteration of knee kinematics, thereby putting undo stress on the insert.' -product history review: product history review could not be performed due to insufficient information.-complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: it was reported that 'at present, the patient has worn out his polyethylene liner, resulting in mcl attenuation and anteromedial subluxation, and an extremely unstable knee.Plastic surgery has evaluated the patient due to his poor wound healing potential, and believe he has an extremely high chance of a wound healing complication with any surgical insult.To reduce the likelihood of a complication, i'd like to perform a polyethylene liner exchange, as opposed to a complete revision, if possible.The liner exchange would provide knee stability without the soft tissue and bony trauma from an extensive, full component revision, and reduce the likelihood of a complication.' a review of the provided medical records by a clinical consultant indicated the following: 'i can confirm that the patient underwent a right kinemax plus total knee arthroplasty since i was able to see an x-ray with the implant in place.The root cause of this event cannot be determined with certainty.The causes of polyethylene wear at 24 years after implantation are multifactorial.These causes include surgical technique in the way the implant is positioned and balanced with proper restoration of the kinematics of the knee.Other contributing causes include patient factors such as the patient's activity level, lifestyle and bmi.While polyethylene wear is an implant issue, i could not assign any causality to the implant unless it could be shown that there was some defect in the manufacturing process.Wear of the polyethylene component can be attributed to development of ligamentous laxity with alteration of knee kinematics, thereby putting undo stress on the insert.' 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.
Event or Problem Description
No new information.

• Brand Name: KX+ DURAT LS INSERT LRG 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 23334762
• Report Number: 0002249697-2025-01137
• Device Sequence Number: 10572505
• Product Code: JWH
• UDI-Device Identifier: 07613327046984
• UDI-Public: 07613327046984
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K921640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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 Catalogue Number: 64795315
• Device Lot Number: 8VMT / 9817399
• 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: 11/16/2023
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male
• Patient Weight: 111 KG