MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI DUR REG FLUTED STEM14X155MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	6478-6-705
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/26/2023
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.H3 other text : device not returned to the manufacturer.
Event or Problem Description
Surgeon reported the non-connection between the femoral component and the taproot.Polio patient treated 3 months ago for revision of knee prosthesis by affixing of mrh system.About three months after the operation, the patient returns for examination and the complete decoupling between the stem and the femoral component is detected by radiographic examination.The femoral part was revised using the gmrs system.
Event or Problem Description
Surgeon reported the non-connection between the femoral component and the taproot.Polio patient treated 3 months ago for revision of knee prosthesis by affixing of mrh system.About three months after the operation, the patient returns for examination and the complete decoupling between the stem and the femoral component is detected by radiographic examination.The femoral part was revised using the gmrs system.
Additional Manufacturer Narrative
An event regarding disassociation involving a duracon 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 information by a clinical consultant indicated: "the undated ap knee x-ray shows a distal femoral replacing tka.With separation of the distal femoral component and the femoral stem.The lateral x-ray (presumably taken following the revision) shows a distal femoral replacing knee with a gmrs style femoral stem.Separation of a stem from a distal femoral replacing component is confirmed.The root cause for this mechanical complication cannot be determined from the limited documentation provided." 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 disassociation of the stem from the femoral component.A review of the provided medical information by a clinical consultant indicated: "the undated ap knee x-ray shows a distal femoral replacing tka.With separation of the distal femoral component and the femoral stem.The lateral x-ray (presumably taken following the revision) shows a distal femoral replacing knee with a gmrs style femoral stem.Separation of a stem from a distal femoral replacing component is confirmed.The root cause for this mechanical complication cannot be determined from the limited documentation provided." further information such as return of the device, pathology reports, additional 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.It was reported that the patient has polio, and this pre-existing condition may have contributed to the device failure.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.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a duracon stem was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: visual inspection: the surface of the stem has damage resulting from explantation.Thread damage observed.Clinician review: a review of the provided medical information by a clinical consultant indicated: "the undated ap knee x-ray shows a distal femoral replacing tka.With separation of the distal femoral component and the femoral stem.The lateral x-ray shows a distal femoral replacing knee with a gmrs style femoral stem.Separation of a stem from a distal femoral replacing component is confirmed.The root cause for this mechanical complication cannot be determined from the limited documentation provided." 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 disassociation of the stem from the femoral component.A review of the provided medical information by a clinical consultant indicated: "the undated ap knee x-ray shows a distal femoral replacing tka.With separation of the distal femoral component and the femoral stem.The lateral x-ray shows a distal femoral replacing knee with a gmrs style femoral stem.Separation of a stem from a distal femoral replacing component is confirmed.The root cause for this mechanical complication cannot be determined from the limited documentation provided." visual inspection of the returned device indicated that the surface of the stem has damage resulting from explantation.Thread damage was also observed.Functional and dimensional inspection not performed as the devices were returned damaged and any inspection would not be indicative of its manufactured state.Further information such as pathology reports, additional 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.It was reported that the patient has polio, and this pre-existing condition may have contributed to the device failure.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.
Event or Problem Description
Surgeon reported the non-connection between the femoral component and the taproot.Polio patient treated 3 months ago for revision of knee prosthesis by affixing of mrh system.About three months after the operation, the patient returns for examination and the complete decoupling between the stem and the femoral component is detected by radiographic examination.The femoral part was revised using the gmrs system.

• Brand Name: TI DUR REG FLUTED STEM14X155MM
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17350025
• Report Number: 0002249697-2023-00793
• Device Sequence Number: 6042170
• Product Code: JWH
• UDI-Device Identifier: 07613327045017
• UDI-Public: 07613327045017
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K973164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2023

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 Model Number: 6478-6-705
• Device Catalogue Number: 64786705
• Device Lot Number: 0118641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 07/27/2023; 11/10/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 08/17/2023; 12/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2022
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White