MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER BIOMET PERSONA REVISION KNEE SYSTEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Device Problems Patient-Device Incompatibility (2682); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Joint Laxity (4526)

Event Date 10/30/2019

Event Type  Injury  

Event Description

In 2019 i had 2 total knee replacements and in 2020 and 2021 i had 2 knee revisions.All 4 surgeries used the zimmer biomet persona knee systems.The left knee had to have a revision because of flexion instability and the right knee had to have a revision because the zimmer persona trabecular tibial plate loosened.I also had to have a right knee debridement in (b)(6) 2020 and an open synovectomy knee with polyethylene exchange on (b)(6) 2022.I am still having problems with both knees.I tried reaching out to zimmer but wasn't successful.I also tried to join the zimmer lawsuit but was not successful at that either.Reference reports: mw5147713, mw5147714, mw5147716.

Event Description

Additional information received from reporter on 11/9/2023 for report mw5147715.On (b)(6) 2023 i am meeting with an orthopedic surgeon at the mayo clinic in (b)(6) due to continuing and ongoing chronic problems with the zimmer biomet persona knee systems installed now.I have the lot #'s, the edi #'s, the ref #'s of all the parts used for both the replacements and the revisions.

• Brand Name: ZIMMER BIOMET PERSONA REVISION KNEE SYSTEM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 18065233
• MDR Text Key: 327588737
• Report Number: MW5147715
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALLOPURINOL; ATORVASTATIN; DULOXETINE; GABAPENTINE; METOPROLOL TARTRATE; MULTI VITAMIN; NITRO; NYSTATIN ; PRAMIPEXOLE; PRILOSEC ; SPIRONOLACTONE; TORSEMIDE; TRAMADOL; TYLENOL ; VITAMIN B12; VITAMIN D; XARELTO; ZOFRAN
• Patient Outcome(s): Other; Hospitalization; Disability
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White