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

Catalog Number	6194-1-001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Daughter of patient reported that within a year of primary right knee surgery, (b)(6) 2019, her mother experienced implant "failure" and within two years required a revision, april 7, 2021.Patient experienced a femur fracture during the revision which required a "rod" to be placed.Patient currently experiences right knee stiffness and swelling.Patient did experience pain at/around her third post op visit which she reported to her surgeon at the time.Patient confirmed that she was actively doing physical therapy at the time of the onset of pain.Daughter is inquiring if implants are subject to a recall.Update 11/14/2023: per medical review addendum, the surgeon found malrotation of both femur and tibia contributing to the patient¿s symptoms, as well as most likely loosening of the femoral component based upon ease of removal.Update: 11/27/2023: per med review, the surgeon states there was notice of part of the cement mantle being broken off at approximately 3 months after the surgery.
Event or Problem Description
Daughter of patient reported that within a year of primary right knee surgery, (b)(6) 2019, her mother experienced implant "failure" and within two years required a revision, (b)(6) 2021.Patient experienced a femur fracture during the revision which required a "rod" to be placed.Patient currently experiences right knee stiffness and swelling.Patient did experience pain at/around her third post op visit which she reported to her surgeon at the time.Patient confirmed that she was actively doing physical therapy at the time of the onset of pain.Daughter is inquiring if implants are subject to a recall.Update (b)(6) 2023: per medical review addendum, the surgeon found malrotation of both femur and tibia contributing to the patient¿s symptoms, as well as most likely loosening of the femoral component based upon ease of removal.Update: (b)(6) 2023: per med review, the surgeon states there was notice of part of the cement mantle being broken off at approximately 3 months after the surgery.
Additional Manufacturer Narrative
An event regarding loosening involving simplex cement mix was reported.The event was 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 with a clinical consultant indicated "this patient suffered early failure of a cemented primary total knee arthroplasty after less than two years.No pertinent clinical information regarding the mode of failure was provided except for a notice of part of the cement mantle being broken off at approximately 3 months after the surgery.I can confirm that the primary procedure and revision procedure took place since i was able to review the xrays.The root cause of this event cannot be determined with certainty with the information provided.I see no obvious cause of failure although at less than two years after surgery, failure modes include infection, loosening, instability, and stiffness.Causes are multifactorial including issues related to surgical technique, patient activity level and bmi.With the information provided i would not assign any causality to the implant itself.Based upon the x-rays of the right triathlon total knee arthroplasty taken on (b)(6) 2020, i do not see an obvious failure mode.However x-rays taken on (b)(6) 2021, show the revision implant in place.I would need more information regarding the immediate pre-revision clinical situation and radiographic situation in order to assess the root cause or contributory causes to the failure.Upon review of the revision operation report, the surgeon found malrotation of both femur and tibia contributing to the patient¿s symptoms, as well as most likely loosening of the femoral component based upon ease of removal.The root cause of malrotation and malposition of the femoral and tibial component is clearly iatrogenic.Anatomical landmarks must be used in order to be certain of the proper position and rotation.I would not assign any causality to the implant itself.The complication of a fracture of the metaphyseal region of the femur is also iatrogenic as well." product history review: as per the oem, "check of batch documentation, no deviations." complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of medical records with a clinical consultant indicated "this patient suffered early failure of a cemented primary total knee arthroplasty after less than two years.No pertinent clinical information regarding the mode of failure was provided except for a notice of part of the cement mantle being broken off at approximately 3 months after the surgery.I can confirm that the primary procedure and revision procedure took place since i was able to review the xrays.The root cause of this event cannot be determined with certainty with the information provided.I see no obvious cause of failure although at less than two years after surgery, failure modes include infection, loosening, instability, and stiffness.Causes are multifactorial including issues related to surgical technique, patient activity level and bmi.With the information provided i would not assign any causality to the implant itself.Based upon the x-rays of the right triathlon total knee arthroplasty taken on (b)(6) 2020, i do not see an obvious failure mode.However x-rays taken on (b)(6) 2021, show the revision implant in place.I would need more information regarding the immediate pre-revision clinical situation and radiographic situation in order to assess the root cause or contributory causes to the failure.Upon review of the revision operation report, the surgeon found malrotation of both femur and tibia contributing to the patient¿s symptoms, as well as most likely loosening of the femoral component based upon ease of removal.The root cause of malrotation and malposition of the femoral and tibial component is clearly iatrogenic.Anatomical landmarks must be used in order to be certain of the proper position and rotation.I would not assign any causality to the implant itself.The complication of a fracture of the metaphyseal region of the femur is also iatrogenic as well." the patient would like to know if her implants were subject to a recall and it has been confirmed that these devices are not subject to a recall.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, as per the oem: "to exclude a product specific cause, the batch documentation was checked, no deviations were detected.A retain sample test was no longer possible as the cement has now passed its expiration date.A user or patient specific cause is possible.A report to fda has been done.".

• 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: 18312833
• Report Number: 0002249697-2023-01548
• Device Sequence Number: 6151957
• Product Code: LOD
• UDI-Device Identifier: 04260056885747
• UDI-Public: 04260056885747
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K123225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• 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: 843AA924EZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 12/12/2023
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: Black Or African American