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

Model Number	6197-9-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "about 3-4 weeks post reimplantation surgery, the subject continued to have drainage from her left knee.Repeat aspiration was still positive for infection.At this time the infection has become chronic and and the patient was indicated for an explant and placement of a static antibiotic spacer.Findings: gross intraoperative purulence with inflamed synovium well fixed femoral and tibial and patellar components." update 02 june 2022.Based on the medical review " while extracting cement from the femoral canal there was a ¿small fracture" of the anterior cortex which was treated with a single cable".The procedure was completed inserting a static spacer.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving simplex cement mix was reported.The event was confirmed through clinician review of the provided medical records.Method & results: device 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 records by a clinical consultant indicated: this inquiry reports recurrent infection of a left knee arthroplasty.Treatment included initial removal of a partial knee replacement and insertion of a spacer.A reimplantation was performed but infection returned.The reimplanted arthroplasty was then removed and a spacer was inserted.I can confirm that this event took place since i was able to review at least 2 of the 3 operations, including the reimplantation following infection treatment and then the removal of the implant and reinsertion of another spacer for infection.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of infection following total knee arthroplasty are multifactorial including surgical technique factors and patient factors, as well as hematogenous spread from a distant site.Device history review: review of the batch manufacturing records indicate packs were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been 2 other similar events for the reported lot.Elates to infection for the same patient, therefore no further trending is required for this commonality.Conclusion: a review of the provided medical records by a clinical consultant indicated: this inquiry reports recurrent infection of a left knee arthroplasty.Treatment included initial removal of a partial knee replacement and insertion of a spacer.A reimplantation was performed but infection returned.The reimplanted arthroplasty was then removed and a spacer was inserted.I can confirm that this event took place since i was able to review at least 2 of the 3 operations, including the reimplantation following infection treatment and then the removal of the implant and reinsertion of another spacer for infection.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of infection following total knee arthroplasty are multifactorial including surgical technique factors and patient factors, as well as hematogenous spread from a distant site.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: simplex p with tobramycin 1 pack; cat#6197-9-001 ; lot#mfc039 simplex p with tobramycin 1 pack; cat#6197-9-001 ; lot#mfc039 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• 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: 14797102
• Report Number: 0002249697-2022-00909
• Device Sequence Number: 5876700
• Product Code: LOD
• UDI-Device Identifier: 07613327128420
• UDI-Public: 07613327128420
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K014199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2022

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 Expiration Date: 03/31/2023
• Device Model Number: 6197-9-001
• Device Catalogue Number: 6197-9-001
• Device Lot Number: MFC039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White