MAUDE Adverse Event Report: STRYKER(SUZHOU) MEDICAL TECHNOLOGY CO.,LTD. TRIATHLON LEFT KNEE REPLACEMENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number SIZ4 TIB 11MMINSERT 5FEMUR 32PA

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 03/22/2019

Event Type  Injury  

Event Description

I received a stryker triathlon left knee replacement.When i awoke, my left foot was turned inward.The pain after replacement was very severe.I entered rehabilitation in a nursing home facility for 10 days during which the therapists worked to straighten out my foot.I went for 5 more weeks of in home and outpatient therapy which never resolved the constant ache or pain.I explained this to the surgeon who said it would take up to one year to resolve.Xrays every few months-no conclusions.At year's end, he finally noted the pain was up to my thigh in his notes.He had no suggestions but a knee brace which did not help.The pain never resolved ranging from aggravating pain to severe pain to throbbing pain.Soon the pain was back now from hip to calf (left side).I tried acupuncture for the knee and hip for over 1 1/2 years.But, no full relief.Xrays and a by 2021, i could no longer walk around the block without stopping many times due to the pain.Driving became a problem and my knee would throb during the night and wake me up.I sought out a hip and another knee surgeon for second opinions.Both doctors had no real answers.Xrays showed it ok they said but my scar was crooked meaning the placement was off.I was told the knee surgery scar seemed off center and finally a fifth surgeon who specializes in resolving knee replacement issues said he saw valgus or turning in of the leg which i did not have prior to the knee replacement.No one suggested another replacement; one of these surgeons saying it would only be 10% effective.I finally sought out a pain clinic which gave me three genicular left knee blocks (b)(6) 2021.Due to my reactive hypoglycemia, these shots have to be monitored carefully as i also have adrenal insufficiency.This has offered a few weeks relief.Another is scheduled (b)(6) 2021.I continue with acupuncture.I believe something is wrong with this knee replacement.According to the surgeon who did the left knee replacement, i had a stryker triathlon right knee replacement in 2009 and never had these issues.I have had numerous xrays, mri's, ct scans and injections.This constant seeing doctors and going for these tests is exhausting.I am a senior with other health issues.The pain is exhausting and interferes with my life.I am now waiting to see a surgeon in (b)(6) hospital clinic ( shoulder and knee) for knee.Hopefully, he can offer a permanent solution.Fda safety report id# (b)(4).

Event Description

Additional information received on 02/16/2022 from a reporter for report number mw5105545.This is an addendum to my previous report in 2021.I received a stryker "telethon" left knee replacement.Pain continuous after implant.Saw 3 other orthopedic surgeons ((b)(6) who sent me to (b)(6) and then to (b)(6).) i then saw dr.(b)(6) of (b)(6) who did an alignment xray which was never done in (b)(6) by the 3 othos i saw.(b)(6) told me my knee replacement had been misaligned and was placed 5 degrees off.Xrays showed the left thigh bone also out of place.This explains the constant pain in the left knee replacement radiating to the left hip and down to the left calf.In my previous report, i noted i was to see an ortho at (b)(6).That was an error.It should have said (b)(6).Due to my age and covid, dr.(b)(6) does not recommend revision surgery as it is (in his words) a long and painful surgery and recovery worse than the first replacement.I saw a specialist at (b)(6) pain clinic who recommended genicular nerve blocks every 8 weeks and as i explained in my complaint last year, this means constant monitoring as i have ai from too many steroid blocks for failed back surgery.Dr (b)(6) at (b)(6) said to do these as long as they help- if not, i have to decide on revision surgery.I note stryker telethon has had many recalls and feel the cutting tool or some other tool used by stryker in this surgery contributed to this misplacement.Stryker telethon cutting tool or some other tool contributed to this misalignment; fda has several recalls.(b)(4).

• Brand Name: TRIATHLON LEFT KNEE REPLACEMENT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER(SUZHOU) MEDICAL TECHNOLOGY CO.,LTD.
• MDR Report Key: 12868802
• MDR Text Key: 281286693
• Report Number: MW5105545
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: SIZ4 TIB 11MMINSERT 5FEMUR 32PA
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2022
• Patient Sequence Number: 1
• Treatment: ALEVE PRN ; CVS DAILY VITAMIN ; GABAPENTIN ; HIZENTRA; METAMUCIL ; MUCINEX ; SUCRALFATE ; TYLENOL ; VERAPAMIL ; ZYRTEC
• Patient Outcome(s): Required Intervention; Hospitalization; Disability; Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White