MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_STRYKER KNEE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348); Post Operative Wound Infection (2446)

Event Date 06/08/2020

Event Type  Injury  

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 Description

As part of 2018-008 x3 knee 10 year multicenter iis, the following was reported: bmi 30.12; underwent right tka for osteoarthritis; revised due to infection 10.7 years after index surgery.

Manufacturer Narrative

Reported event an event regarding infection involving an unknown knee was reported.The event was confirmed by clinician review.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: "(b)(6) 2008 brief op note right total knee replacement diagnosis: right knee arthritis ".Using universal instrumentation.Cemented components.Excellent stability." uncomplicated surgery.(b)(6) 2019 brief op note i & d , removal components, antibiotic spacer right knee diagnosis: "infected right knee replacement" ".Removed components.Spacer with 3 units of antibiotic cement." uncomplicated surgery.Office visits (b)(6) 2019, (b)(6) 2019/ (b)(6) 2019 for follow-up prior to reimplantation.(b)(6) 2019 brief op note revision right tka diagnosis: "failed right tka secondary to infection" ".Removed spacer components.Inserted stryker #4 femur, 2 - 5mm posterior augments, 2 - 5mm distal augments, 18/100 stem, #4 tibial baseplate, 2- 10mm tibial augments, size b tibial cone, vancomycin simplex cement." uncomplicated surgery.(b)(6) 2019 staples removed.(b)(6) 19".Progressing well with pt." (b)(6) 2019 " x-ray right knee good alignment.Without loosening.C/o left knee pain.Follow-up 6 weeks." no subsequent follow-up documented.No clinical or pmh, no patient demographics, no imaging studies, no listing of primary tka components, no examination of explanted components, no infectious disease consultation or bacteriology lab.Reports.There is no indication this late periprosthetic knee infection was related to implant material or manufacturing, and the event description is confirmed by the operative reports.A complete comprehensive medical report is not possible based upon the presented information for this case." -product history review: not performed as the device lot details were not provided.-complaint history review: not performed as the device lot details were not provided.Conclusions: clinician review revealed that there is no indication this late periprosthetic knee infection was related to implant material or manufacturing, and the event description is confirmed by the operative reports.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as clinical or patient medical history (pmh), patient demographics, imaging studies, primary tka components details, examination of explanted components, and infectious disease consultation or bacteriology lab reports are needed to complete the investigation for determining root cause.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 Description

As part of 2018-008 x3 knee 10 year multicenter iis, the following was reported: bmi 30.12; underwent right tka for osteoarthritis; revised due to infection 10.7 years after index surgery.

• Brand Name: UNKNOWN_STRYKER KNEE
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10187977
• MDR Text Key: 196209673
• Report Number: 0002249697-2020-01264
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR