MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX HV US 1 PACK; BONE CEMENT

Catalog Number	6194-1-001
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revised a right triathlon femur and insert due to femoral loosening.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
An event regarding loosening involving a simplex cement mix 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 medical records by clinician indicated "cap this patient underwent an initial unicompartmental arthroplasty which failed in 2017.A revision was carried out in 2024.I can confirm that the patient underwent the revision in 2017 since i was able to see an operation report indicating revision surgery.I cannot confirm the revision in 2024 since i have no documentation such as operation reports, doctors notes or any x-rays.The root cause of failure of a unicompartmental knee replacement in this case cannot be determined with certainty.In the operation note for the revision there was no mention of what the pathology was and what condition he was correcting.In general the causes of multifactorial including surgical technique, indication, patient activity level and bmi.Unless the implant failure was for breakage or polyethylene wear, i would not implicate the prosthesis as a causative factor.Regarding revision for a loose femoral component, the root cause again in this case cannot be determined with certainty.No x-rays were provided or any office notes.Causes of femoral loosening of the cemented component include surgical technique especially in the manner of implantation and cement procedure.Causes also include patient factors such as activity level and bmi.Unless there is a breakage of the component, i would not assign any causality to the component itself unless evidence was provided to the contrary.[¿] product history review: oem reported, "check of batch documentation, no deviations." 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 loosening.A review of medical records by clinician indicated "cap this patient underwent an initial unicompartmental arthroplasty which failed in 2017.A revision was carried out in 2024.I can confirm that the patient underwent the revision in 2017 since i was able to see an operation report indicating revision surgery.I cannot confirm the revision in 2024 since i have no documentation such as operation reports, doctors notes or any x-rays.The root cause of failure of a unicompartmental knee replacement in this case cannot be determined with certainty.In the operation note for the revision there was no mention of what the pathology was and what condition he was correcting.In general the causes of multifactorial including surgical technique, indication, patient activity level and bmi.Unless the implant failure was for breakage or polyethylene wear, i would not implicate the prosthesis as a causative factor.Regarding revision for a loose femoral component, the root cause again in this case cannot be determined with certainty.No x-rays were provided or any office notes.Causes of femoral loosening of the cemented component include surgical technique especially in the manner of implantation and cement procedure.Causes also include patient factors such as activity level and bmi.Unless there is a breakage of the component, i would not assign any causality to the component itself unless evidence was provided to the contrary.[.]additionally, the reported device is an oem product.Written acknowledgement from the oem supplier that an investigation has been initiated at the oem supplier site was received, and has been attached within the communication log.See supplier issue ref #(b)(4).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.Additionally, the oem reported the following: possible reasons for loosening and subsequent revision can be product-, patient- or user-related.To exclude a product specific cause, the batch documentation was checked.No deviations were detected.Therefore a product specific cause can be excluded.This complaint will be closed.
Event or Problem Description
Revised a right triathlon femur and insert due to femoral loosening.

• Brand Name: SIMPLEX HV US 1 PACK
• Common Device Name: BONE CEMENT
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18779364
• Report Number: 0002249697-2024-00293
• Device Sequence Number: 8382593
• Product Code: LOD
• UDI-Device Identifier: 04260056885747
• UDI-Public: 04260056885747
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 6194-1-001
• Device Lot Number: 701AA992MX
• 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: 01/30/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 62 YR
• Patient Sex: Female