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

Catalog Number	6194-1-001
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/19/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Pt.Called to report that they had a procedure on (b)(6) 2023 with stryker implants on their left knee.They stated that they experienced loosening and some of the implant failed.They would like to file a claim.Additional info.27-nov-2024: revision on (b)(6) 2023.Dec 20.2024- as per medical review, the patient was revised due to tibial loosening and rom.An additional record was created fort he mua after revision.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a simplex cement mix was reported.The event was confirmed via medical review.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 "patient underwent a tka with the robot.The procedure appeared routine.The decision for uni vs total was made in the or and a decision to move to total based on the trochlear cartilage.No preoperative records or radiographs were provided for review.The postoperative course and complete x-rays were not provided for review.The patient presented for a second opinion, the reasons appeared to be dissatisfaction with the knee¿s rom and some pain.In the second opinion it was stated that there was a proposal for a debridement and poly exchange as a treatment course.The second opinion did order hip x-rays and an mri to evaluate radicular like pan in the left lower extremity.The knee evaluation was not particularly specific.After checking inflammatory markers, it was felt that revision was in order for a loose tibia and stiffness, the description of x-rays was simply loosening along the tibia.An evaluation of the loosening was not given.The revision operative note was not provided.Postoperatively from the revision the patient underwent mua for stiffness.The course thereafter was not provided for review.Event confirmation: a revision surgery of a mako tka was performed.An mua was also performed on the revision.Two reasons for the revision were given the first, stiffness, can be confirmed from the record.The second, tibial loosening, cannot be confirmed.Root cause: the root cause of the revision was stiffness and presumed tibial loosening.The tibial loosening could not be confirmed and thus no root cause can be attributed.The root cause of the stiffness cannot be ascertained." -product history review: a review of the device history records was not performed as the device is oem.-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."patient underwent a tka with the robot.The procedure appeared routine.The decision for uni vs total was made in the or and a decision to move to total based on the trochlear cartilage.No preoperative records or radiographs were provided for review.The postoperative course and complete x-rays were not provided for review.The patient presented for a second opinion, the reasons appeared to be dissatisfaction with the knee¿s rom and some pain.In the second opinion it was stated that there was a proposal for a debridement and poly exchange as a treatment course.The second opinion did order hip x-rays and an mri to evaluate radicular like pan in the left lower extremity.The knee evaluation was not particularly specific.After checking inflammatory markers, it was felt that revision was in order for a loose tibia and stiffness, thee description of x-rays was simply loosening along the tibia.An evaluation of the loosening was not given.The revision operative note was not provided.Postoperatively from the revision the patient underwent mua for stiffness.The course thereafter was not provided for review.Event confirmation: a revision surgery of a mako tka was performed.An mua was also performed on the revision.Two reasons for the revision were given the first, stiffness, can be confirmed from the record.The second, tibial loosening, cannot be confirmed.Root cause: the root cause of the revision was stiffness and presumed tibial loosening.The tibial loosening could not be confirmed and thus no root cause can be attributed.The root cause of the stiffness cannot be ascertained." additionally, the reported device is an oem product.Written acknowledgement from the oem supplier confirmed that they have done retain tests and found no deviations.See supplier issue ref #rm2024/146.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
Pt.Called to report that they had a procedure on (b)(6) 2023 with stryker implants on their left knee.They stated that they experienced loosening and some of the implant failed.They would like to file a claim.Additional info.27-nov-2024: revision on (b)(6) 2023.Dec 20.2024- as per medical review, the patient was revised due to tibial loosening and rom.An additional record was created fort he mua after revision.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20999381
• Report Number: 0002249697-2024-01782
• Device Sequence Number: 21373038
• Product Code: LOD
• UDI-Device Identifier: 04260056885747
• UDI-Public: 04260056885747
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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: 6194-1-001
• Device Lot Number: 211AC9621C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 04/22/2025
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 190 KG
• Patient Ethnicity: Hispanic