MAUDE Adverse Event Report: EXACTECH, INC. KNEE REPLACEMENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Device Problems Loose or Intermittent Connection (1371); Use of Device Problem (1670)

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

Event Date 09/23/2013

Event Type  Injury  

Event Description

I had right tkr on above date and have had worsening swelling and pain for the past 10 years.I have seen multiple orthopedic surgeons, had multiple x-rays, nuclear med tests, pain meds, and physical therapy sessions to no avail.My pain has affected my lifestyle, outings with family and grandchildren, vacations, and daily chores like cleaning, grocery shopping and errands.Report: no scintigraphic evidence for osteomyelitis; progressive increasing accumulation radiotracer uptake on blood pool and delayed images in the region of the right lateral femoral condyles and medial tibial plateau adjacent to indwelling hardware which potentially may represent areas of hardware loosening.

• Brand Name: KNEE REPLACEMENT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.
• MDR Report Key: 17019930
• MDR Text Key: 316214542
• Report Number: MW5117954
• 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
• Report Date: 05/24/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2023
• Patient Sequence Number: 1
• Treatment: ALPRAZOLAM.25-.50 MG AS NEEDED ; CALCIUM; COLESTIPOL 2MG 2XDAILY ; DICLOFENAC LOTION AS NEEDED ; DULOXETINE 90 MG 1XDAILY ; HYDROCORTISONE CREAM 2.5% AS NEEDED ; IRON; LEVOTHYROXINE 137 MCMG 1XDAILY ; LISINOPRIL 30MG 1XDAILY ; METROPOLOL 50 MG 1XDAILY ; MULTIPLE VITAMIN; TRAMADOL 50-100 MG AS NEEDED; TRAZADONE 100 MG 1XDAILY ; VITAMIN D
• Patient Outcome(s): Other; Disability
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Race: White