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 Problem Pain (1994)

Event Date 03/13/2024

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

It was reported via the stryker facebook page, "i had a stryker tkt on my left knee in (b)(6) 2020.At 7 months i woke up and a bunch of b-b like things had come to surface.The surgeon said they were internal sutures that weren't to come out but they did and i was told it was cosmetic and they would leave them alone.Well, i complained of burning pain continually from that time forward and at one year i was told some people still have pain after one year.So i walked on that painful knee for 9 more months till i asked another surgeon, who just did my shoulder surgery.He said the sutures were my problem.He was right and after his surgery to remove them, i had to deal with all the issues of damage from walking on that painful knee, it band issue, etc.After a lot of pt it became much better, no burning pain, but always stiff.Then i fell on that leg on thanksgiving 2023 and had to get a new left hip.I now have one leg longer than the other.The hip seemed okay but i had extreme sharp pain inside the left knee cap with any movement.I also had it buckle on me and it was swelled and hot.My hip surgeon did knee x-rays and blood work to rule out infection said it didn't show any damage and the pain was blamed on the leg length discrepancy.But, feb 25 i got on an elliptical and that night the inside pain was gone and it only felt bruised and the usual stiff.The intense pain inside my knee is gone but i still have a very stiff knee and very sore around that knee and now hip issues due to a longer leg.Should i blame the leg length discrepancies now? could i have thrown that knee out of alignment on that thanksgiving fall? if i am told i ever need to get my right knee done i am thinking i might feel suicidal.I knew i needed a new left knee but damn i went through hell and i am a mother of 4 kids and have never been known as a wimp.Every story i hear of people with no problems with their new knees, it infuriates me that i wasn't so lucky.".

• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 19056301
• MDR Text Key: 339548145
• Report Number: 0002249697-2024-00553
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2024
• 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