MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS 13MM X 127MM FEMORAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64853013
Medical Device Problem Codes	Failure to Osseointegrate (1863); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient-specific implant prescription was received for the patient's left gmrs distal femur.Noted on the form: "loosening stem." as an first stage of revision, cement spacer fixed.
Additional 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.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving an mrs stem was reported.The event was confirmed via clinician review of the provided medical records.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: "this patient underwent what was most likely a tumor resection with implantation of a distal femoral and proximal tibial replacement with cemented stems.Approximately nine years after implantation the patient developed polyethylene wear and a fracture of the femoral component.Subsequently the patient developed aseptic loosening.I can confirm that the patient had a procedure with a tumor type prosthesis since i was able to see the x-rays.The x-rays are compatible with loosening of the femoral component.I cannot confirm any of the other surgeries because i have no documentation such as office notes, operation notes or sequential revision x-rays.The root cause of these events cannot be determined with certainty.The root causes of polyethylene wear are multifactorial including surgical factors such as technique, ligament balancing and restoration of proper kinematics.Patient factors include activity level and bmi.Implant factors can also contribute.In this case the use of a mega prosthesis in a relatively young patient can lead to polyethylene wear.Causes of implant fracture are also multifactorial including surgical technique factors with proper support for the implant and cementing technique as well as ligament balancing and restoration of kinematics.Patient activity level and bmi can also contribute.The removed should be submitted to stryker engineers for examination and evaluation to determine if any defects were present in the implant.Loosening of a cemented mega prosthesis is not unusual.The use of a heavy implant with cemented medium length stems can eventually result in loosening depending on the alignment, cement technique and patient activity level and bmi." -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 aseptic loosening of the femoral stem.The event was confirmed by clinician review of the provided medical records: "this patient underwent what was most likely a tumor resection with implantation of a distal femoral and proximal tibial replacement with cemented stems.Approximately nine years after implantation the patient developed polyethylene wear and a fracture of the femoral component.Subsequently the patient developed aseptic loosening.I can confirm that the patient had a procedure with a tumor type prosthesis since i was able to see the x-rays.The x-rays are compatible with loosening of the femoral component.I cannot confirm any of the other surgeries because i have no documentation such as office notes, operation notes or sequential revision x-rays.The root cause of these events cannot be determined with certainty.[.] loosening of a cemented mega prosthesis is not unusual.The use of a heavy implant with cemented medium length stems can eventually result in loosening depending on the alignment, cement technique and patient activity level and bmi." 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.Correction: d6a.
Event or Problem Description
A patient-specific implant prescription was received for the patient's left gmrs distal femur.Noted on the form: "loosening stem." as an first stage of revision, cement spacer fixed.Update: patient was underwent stage 1 of a left distal femur revision on (b)(6) 2023 due to aseptic loosening of the femur stem.The femoral components were explanted and the patient was closed back up with a cement spacer and above the knee cast applied as the surgeon requires a custom device to accommodate the patient's wide femur medullary canal of more that 17mm.The second stage of this revision was reported to be planned for (b)(6) 2023 during which the custom femoral implant would be implanted.

• Brand Name: MRS 13MM X 127MM FEMORAL STEM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17339701
• Report Number: 0002249697-2023-00783
• Device Sequence Number: 20561112
• Product Code: KRO
• UDI-Device Identifier: 07613327048315
• UDI-Public: 07613327048315
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K040749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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: 06/30/2024
• Device Catalogue Number: 64853013
• Device Lot Number: 204572C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2019
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White