MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P SPEEDSET FULL DOSE 1 PACK; BONE CEMENT, ANTIBIOTIC

Model Number	6192-1-001
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	10/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding revision due to loosening involving a simplex cement mix was reported.The event was not confirmed.Method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: the available medical records were provided to the consulting clinician for a review which noted that, "this event which represents a female patient, dob (b)(6) whose date of implantation is listed as (b)(6) 2016 and explantation (b)(6)2017.The event description states: ".Through.Attorney.Revised due to painful, failed left tka." (b)(6) 2016 op report: "left knee arthroplasty" for "left knee djd" cemented components - uncomplicated surgery.(b)(6) 2017 op report: "revision left tka - femoral and tibial components for "painful, failed left tka with inadequate fixation of tibial component." ".Tibial and femoral components removed with osteotome - revised to cemented, modular revision components.Uncomplicated surgery - patella not mentioned.(b)(6) 2016 implant labels: triathlon ps tka, symmetric patellar component, simplex p speedset cement.No clinical or pmh, no patient demographics, no imaging studies, no examination of explanted components.Based upon the information available for review, neither confirmation of the event description nor preparation of a medical report is possible for this case.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been 1 other similar events for the reported lot for the same device/patient conclusion: the available medical records were provided to the consulting clinician for a review which noted that, no clinical or pmh, no patient demographics, no imaging studies, no examination of explanted components.Based upon the information available for review, neither confirmation of the event description nor preparation of a medical report is possible for this case.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to painful failed left total knee arthroplasty.Update from med review: "revision left tka - femoral and tibial components' for "painful, failed left tka with inadequate fixation of tibial component." ".Tibial and femoral components removed with osteotome - revised to cemented, modular revision components.Uncomplicated surgery - patella not mentioned.".

• Brand Name: SIMPLEX P SPEEDSET FULL DOSE 1 PACK
• Common Device Name: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12457634
• Report Number: 0002249697-2021-01546
• Device Sequence Number: 11596295
• Product Code: MBB
• UDI-Device Identifier: 07613327128451
• UDI-Public: 07613327128451
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K063857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2021

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: 09/30/2017
• Device Model Number: 6192-1-001
• Device Catalogue Number: 6192-1-001
• Device Lot Number: DJW024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR