MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P WITH TOBRAMYCIN 1 PACK; BONE CEMENT

Catalog Number	6197-9-001
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The following information was provided: it was reported that the patient's knee was revised due to loosening of the tibial component.Intra-operatively, it appeared that the bone cement had de-bonded from the implant.The tibial component and insert were revised.Surgeon would like the device investigated and would like the investigation results.
Event or Problem Description
Update: left side.
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: visual inspection of the implant noted residual bone ingrowth and cement visible.Damage consistent with explanation was observed.Functional analysis was not performed.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: "root cause analysis: the root cause of this event cannot be determined with certainty.In my experience of thousands of cemented triathlon implants debonding of a cemented tibial component has not occurred.The causes of debonding of cement include surgical technique in the preparation of the cement, the timing of cementing and the general cement technique utilized.I would not assign any causality to the patient.Before i would assign any causality to the implant or cement, the implant and the cement mantle should be submitted for analysis to see if there was any material defect.One of the photographed showed what appears to be retained cement along the rim of the tibial component and posterior to it as well as a metal retractor, leaning on the femoral component which was to be retained.Therefore i would question the surgical technique and cementing technique as being possibly causative.N.B.Any and all explanted parts or prostheses should be submitted to stryker engineers for complete metallurgical and/or microscopic evaluation and analysis." -product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient's left knee was revised due to loosening.A review of the provided medical records by a clinical consultant stated the following comment: "root cause analysis: the root cause of this event cannot be determined with certainty.In my experience of thousands of cemented triathlon implants debonding of a cemented tibial component has not occurred.The causes of debonding of cement include surgical technique in the preparation of the cement, the timing of cementing and the general cement technique utilized.I would not assign any causality to the patient.Before i would assign any causality to the implant or cement, the implant and the cement mantle should be submitted for analysis to see if there was any material defect.One of the photographed showed what appears to be retained cement along the rim of the tibial component and posterior to it as well as a metal retractor, leaning on the femoral component which was to be retained.Therefore i would question the surgical technique and cementing technique as being possibly causative.N.B.Any and all explanted parts or prostheses should be submitted to stryker engineers for complete metallurgical and/or microscopic evaluation and analysis." visual inspection of the implant noted residual bone ingrowth and cement visible.Damage consistent with explanation was observed.Functional analysis was not performed.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.

• Brand Name: SIMPLEX P WITH TOBRAMYCIN 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: 24002625
• Report Number: 0002249697-2026-00010
• Device Sequence Number: 16082720
• Product Code: LOD
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K014199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 6197-9-001
• Device Lot Number: MKC067
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 04/25/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2021
• 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: 68 YR
• Patient Sex: Male