FDA Adverse Event Injury Summary report: N

PF WAVE IMPLANT UNICOMPARTMENTAL PATELLOFEMORAL JOINT - PRESS FIT 10 X 5 TROCHLE

MDR report key: 13002325 · Received December 13, 2021

Report

Report Number
MW5106026
Event Type
Injury
Date Received
December 13, 2021
Date of Event
June 24, 2021
Report Date
December 10, 2021
Manufacturer
ARTHROSURFACE, INC.
Product Code
KRR
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

IN 2012 ARTHROSCOPIC SURGERY WAS COMPLETED ON MY RIGHT KNEE WITH LITTLE RELIEF OF PAIN. BOTH OF MY KNEECAPS WERE REPLACED BY AN ORTHOPEDIC SURGEON IN (B)(6). RT KNEE CAP (B)(6) 2016, LEFT KNEECAP (B)(6) 2017. CONTINUED PAIN IN BOTH KNEES. DUE TO UNUSUAL PAIN IN THE LEFT KNEE EARLIER THIS YEAR, IN (B)(6) 2021 X-RAYS REVEALED A DEFECT IN THE LEFT PROSTHETIC; TOTAL LEFT KNEE REPLACEMENT (TKR) IN (B)(6) 2021. PT FOR 3 MONTHS AND CONTINUED WATER THERAPY. IN (B)(6) 2021, X-RAYS REVEALED A "PROMINENT PATELLA ALTA" OF THE RIGHT KNEE AND DOCTORS ARE RECOMMENDING A TKR OF THE RIGHT KNEE. I HAVE NOT HAD A TRAUMATIC INJURY TO MY KNEES. DURING SHELTER IN PLACE GUIDELINES, MY ACTIVITY WAS LIMITED. WITH INCREASED PAIN IN MY KNEES AND BEING DIAGNOSED WITH COMPROMISING MEDICAL ISSUES, MY ACTIVITY & MOBILITY IS STILL LIMITED. RESEARCH STATES THE ARTHROSURFACE KNEECAP PROSTHETICS SHOULD LAST 15-20 YEARS. A CERTIFIED LETTER WAS SENT TO ARTHROSURFACE SEPTEMBER 14, 2021, RECEIVED ON 9-20-2021. NO RESPONSE UNTIL I CONTACTED ARTHROSURFACE ON 9-30-2021. AFTER OUR INITIAL CONVERSATION, NO RESPONSE FROM THE SENIOR ATTORNEY, EVEN AFTER SEVERAL ATTEMPTS TO CONTACT HIM UNTIL NOVEMBER 8, 2021. A LETTER WAS RECEIVED BY EMAILED DENYING ANY ISSUES WITH THEIR IMPLANTS. I'M STILL RECOVERING FROM A TKR IN (B)(6) AFTER THE REMOVAL OF DEFECTIVE IMPLANT FROM MY LEFT KNEE. ANOTHER TKR IS REQUIRED IN THE NEAR FUTURE TO REMOVE THE IMPLANT THAT IS NO LONGER IN THE PROPER POSITION IN MY RIGHT KNEE. DUE TO DIAGNOSIS OF CHRONIC KIDNEY DISEASE, SLE, AND OTHER COMPROMISING MEDICAL ISSUES, I'M HAVING TO ENDURE INCREASED PAIN AND ANXIETY AS I WAIT FOR MY BODY TO RECOVER FROM MY MOST RECENT KNEE SURGERY. THE SURGICAL NOTES FROM (B)(6) 2021 REVEALED THAT THE IMPLANT WAS COMPLETELY BROKEN AND WE ARE NOT SURE WHAT WILL BE REVEALED WHEN SURGERY IS COMPLETED ON THE RIGHT KNEE. MY PRESENT ORTHOPEDIC PRESCRIBED A LARGE BRACE DUE TO THE PROMINENT PATELLA ALTA REVEALED ON MY X-RAYS OF "(B)(6) 2021". FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1885741 PF WAVE IMPLANT UNICOMPARTMENTAL PATELLOFEMORAL JOINT - PRESS FIT 10 X 5 TROCHLE PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER KRR ARTHROSURFACE, INC.
1885742 PF WAVE IMPLANT UNICOMPARTMENTAL PATELLOFEMORAL JOINT - PRESS FIT 10 X 5 TROCHLE PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER KRR ARTHROSURFACE, INC.

Patients

Seq Age Sex Outcome Treatment
1 59 YR Female Disability| R| H| O AMLODIPINE| APPLE CIDER VINEGAR| ATENOLOL| CALCIUM| MAGNESIUM| MULTIVITAMINS| RIGHT PATELLOFEMORAL IMPLANT| VITAMIN C, D