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

Catalog Number UNK_JR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 02/08/2024

Event Type  Injury  

Event Description

It was reported through the stryker facebook page, "i had a total knee replacement with the mako and my knee is worse than it evet was before.I so regret having it done so painful that i will not have the other knee done.Its swelled and in constant pain." additional fb comment received, 2/26/2024: surgery was 5 months ago, i am very disappointed with the outcome/surgery.It was more painful than anything in my life.I have a high tolerance but this is unreal.It still is very restricted and painful, swelled & aches all the time, i can't sleep.And i am doing physical therapy & excercises at home faithfully.I never expected it to take this long, they did tell me a solid year of doing exercises daily, icing taking tylenol & advil.I will not have my other knee done, its bone on bone arthritis as well.I really regret it.This does not feel normal in any way shape or form.And they don't seem to wanna listen or have any answers, they keep saying its to be expected, it just makes me furious.(b)(6) they use the ct scan as a guide but the robotic arm grinds the bad bone & cartikage & tissue away.Cut & re-attatch bone(s) with screws.We bought a 33 foot cabin cruiser to enjoy our retirement, at this point i don't even know if ill be able to climb the ladder & get my leg up & over the 4 foot rail at the top & walk across the bow.Boating was one of the big reasons i had the surgery done, thinking it would be easier and more stable.I sure hope it takes a turn for the better.

Manufacturer Narrative

Reported event: an event regarding pain involving an unknown mako knee was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient is experiencing post-operative pain.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the operative report as well as patient history and follow-up notes 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.

• Brand Name: UNKNOWN_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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19140004
• MDR Text Key: 340564467
• Report Number: 0002249697-2024-00337
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female