MAUDE Adverse Event Report: STRYKER CORP. CEMENTLESS FEMUR MAKO IMPLANT STRYKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2020

Event Type  Injury  

Event Description

Stryker rep did not show up for case.A cementless mako bilateral knee planned and only the mps rep was present because stryker joint rep was too busy to cover.A cemented tka implant was given by rep and implanted in left knee and only noted by rep while doing inventory when right knee was being closed.Nobody noticed it.When i implanted it, i recall i confirmed the sizes and often we trust the reps to show us the correct implants and the sizes and correct side were identified.The mako cut is always good so the fit of the implant was snug.So i did not suspect a problem.When the scrub hands me the implant, it is handed to me loaded on the jig into my hands ready to mallet in place and was taken with the backside facing opposite me and then turned towards the cut femur and hammered in.That implant should never have been handed to the sterile field.A benefit risk decision was made by me to leave the implant in place because i only found out at the end of the 2nd knee (right knee closing) and due to numerous surgical delays, the operative time was too high to warrant opening a well seated implant - it was felt that a good fitting implant would do well even with a fibrous union in the femur rather than opening the knee again for another exposure.Reps often talk about how many cases they have done, and it is disconcerting since none of the reps actually do surgery, but speak of how much experience they have as in the first person as if they are surgeons.This is not just a problem with stryker but many companies.In this case, the 'experience' of the rep failed him in not identifying the wrong type or bar code, noting that the implant was the incorrect backside surface.Ultimately as the operating surgeon i have responsibility, but in surgery, there must be a better more secure way of confirming that the correct, preop templated implant is being passed onto the sterile surgical field.This is a bigger problem than for just stryker and i feel that all joint implants should be immediately stopped until a secure hipaa compliant method of digital confirmation and validation by 2 company reps be done (one could be a bar code scan remotely to another rep) before the implant is even shown to the surgeon.All joint companies must immediately implant a plan to avoid this.The adverse event is cemented implant implanted without cement because the surgeon myself believed it to be a cementless implant which was the plan using a computer navigation and robot mako with preop templating and review.This implant may undergo early aseptic loosening but based on the known low demand of the patient and the small stature, the implant is unlikely to come loose and formed the basis of the benefit risk decision to not open it up again and change the implant.Fda safety report id # (b)(4).

• Brand Name: CEMENTLESS FEMUR MAKO IMPLANT STRYKER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER CORP.; watsonville CA 95076
• MDR Report Key: 10837711
• MDR Text Key: 216410406
• Report Number: MW5097864
• Device Sequence Number: 1
• Product Code: MBH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 70