MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. MEDIUM VISCOSITY CEMENT; BONE CEMENT, ANTIBIOTIC

Catalog Number 5450-50-501

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 11/14/2023

Event Type  Injury  

Event Description

My husband had his right knee replaced in 2017.The surgical procedure appeared to have gone well for about the first three months.Then he began or continued to have pain in his right knee.He followed up with the surgeon who did x-rays and found no issues.The problems continued and he again went in for his one-year post op appointment.He was told that sometimes knee joints don't fit as well for some patients.The pain continued and became so intense at the beginning of 2023 that he sought assistance from a different surgical group.The x-rays immediately showed that the orthopedic joint was moving in his leg.He was told he would have to have a revision surgery for correction.He had this surgery on (b)(6) 2023.We were told by the surgeon that the original replacement failed before my husband¿s knee was even closed up as none of the cement adhered to any part of the artificial joint.The new surgeon had to do extensive debridement of the bones as the cement was in the bones.He said both parts of the original replacement just popped out and it was very lucky my husband did not have a major femur fracture.Also, he had to use a much larger joint for the revision and now it may not last as long as it should.My husband is an active 68-year-old who is still employed.Here are the parts that were originally used.The first number is the manufacturer (catalog) number, and the second number is the lot number of the specific implant used.Attune medial anat pat 38mm: catalog 151810038, lot 8430077.Attune ps rp insrt sz 8 10mm: catalog 151650810, lot 3561102.Attune rp tib base sz 7 cem: catalog 150610007, lot 8411553.Attune ps fem rt sz 8 cem: catalog 150410208, lot 8236457.Medium viscosity cement 2 bags: catalog 5450-50-501, lot 8378515.Reference reports: mw5151849, mw5151850, mw5151851, mw5151852, mw5151854.

• Brand Name: MEDIUM VISCOSITY CEMENT
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 18767307
• MDR Text Key: 336286557
• Report Number: MW5151853
• Device Sequence Number: 1
• Product Code: MBB
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5450-50-501
• Device Lot Number: 8378515
• Patient Sequence Number: 1
• Treatment: ADVIL.; ATORVASTATIN.; ATTUNE MEDIAL ANAT PAT 38MM.; ATTUNE PS FEM RT SZ 8 CEM.; ATTUNE PS RP INSRT SZ 8 10MM.; ATTUNE RP TIB BASE SZ 7 CEM.; BABY ASPIRIN.; COPPER.; DAILY VITAMIN.; HCTZ (HYDROCHLOROTHIAZIDE).; JARDIANCE.; LISINOPRIL.; METFORMIN.; THYROID.
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White