MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. DEPUTY ATTUNE SYNTHESIS TOTAL KNEE REPLACEMENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Patient Problems Hemorrhage/Bleeding (1888); Failure of Implant (1924); Nerve Damage (1979); Ambulation Difficulties (2544); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 12/09/2020

Event Type  Injury  

Event Description

My name is (b)(6).I am 41 years old.I live in (b)(6).My home phone number is (b)(6).I have a depuy knee replacement from (b)(6) hospital.The date the implant impacted my body, and i failed knee replacement was (b)(6) 2020, by a dr (b)(6).The implant was supposed to fit accordingly and has severe failure in the right knee.The tibia bone was not cut which has led to a surgical error.I had an mri completed in 2021 with (b)(6).A dr (b)(6) explain to me as a patient that the cement has caused a void meaning the cement is not manufactured properly.The images are showing darkening inside the cement.Also had a bone scan completed showing loosening in the hardware.The bone cement is between the implant and the bone.Both of these are two traumatic concerns to have from a knee replacement.I've been diagnosed with regional pain syndrome and failed right knee.Total knee replacement.I've had two bone scans completed from 2023 that all showed the included information and regarding the faulty bone cement and hardware loosening.Please if somebody would like to reach out to me in regard to the bone cement failure and tibia surgical error all is documented within the senior reconstructive surgeons that i'm seeing at dr (b)(6).They are both in (b)(6) near my home and both have had me on their schedule for total knee revision replacement.This is a concern to them also with myself to have to let me know that my knee replacement has failed due to manufacturer faulty cement and the surgeon at (b)(6) hospital that did not cut my leg properly resulting in extreme swelling.Also, regional pain syndrome, traumatic hemorrhaging of the nerves, pinched nerves metal on metal, hinged locked knee joint.I know limp and severe pain and have to ice my leg and a laying down position daily.On medications that may be affecting the health and quality of a normal knee replacement.Recipient of my age being explained the severity of the failure to have a total knee replacement going forward needing a revision.I've spoken with depuy.(b)(6) is a caseworker that also knows the manufacturer for depuy.They had called me as a cement manufacturer and gave me a verbal apology about the cement.This was conducted early in 2023.I would like the fda to look into the cement manufacturer.(b)(6) again is a caseworker with depuy.The manufacturer for the cement and (b)(6) also has requested documentation in regards to the knee replacement that is inside my right leg.They both have explained to me that they would request medical records and also paperwork.Neither of these requests have been returned to me.As a patient with failed cement and an oversized knee implant affecting the quality of being able to walk normally, i would like the fda to investigate the cement manufacturer.Also, the patient reporting process that hasn't been completed correctly again.I'm 41 years old my doctors are requesting a total knee revision and the right knee replacement is a depuy a faulty implant.Singed (b)(6).I would please request the help of the fda case administration to conduct an investigation and help me as a replacement patient to investigate the cement manufacturer and depuy in accordance with the other cases and file me as a complaint needing assistance with my failed depuy knee replacement.Failed cement components voided implant on bones and implant replacement.I've had certain mri¿s, ct scans, x-rays, bone scans, genicular nerve testing, and radio frequency testing all which will be documented with the fda case workers.I've been told the cement is voided and the manufacturer has not followed up or sent any information in regard to the request back to me as a patient in a timely manner.Again, the knee replacement was put in at (b)(6) hospital and a faulty surgery where now the total knee replacement is compromised severely and needs a total knee revision which is now can promise from bad cement and tibia replacements.Both the lower and top replacements and the inserts all need to be remeasured and replaced and the cement took an out of my body my pain level every day is between a medical aid to 10 or higher.Please let somebody can reach out to me and assist me with getting the faulty cement issue into your records this is the reason for my notice thank you (b)(6).Severe chronic pain issues traumatic spasms and hemorrhaging of the right leg chronic inflammation a severe pain right knee replacement failure daily medication body pain.I want my case report two include all patient filed medical conditions also dr.(b)(6) too.Fda cases of reported test and implant failures in the depuy replacement prostheses.(b)(6), (b)(6) 1982.41 year old male (b)(6) hospital and depuy knee manufacturer complaint.Contact (b)(6); home address is (b)(6).Morphine immediate release consistent daily icing for regional pain syndrome i also have a cane and medical grade shoes that help with the ongoing pain and knee giving out from my total knee placement and ongoing pain in the device and planted from (b)(6) hospital and depuy.Reference report: #mw5152115.

• Brand Name: DEPUTY ATTUNE SYNTHESIS TOTAL KNEE REPLACEMENT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 18806776
• MDR Text Key: 336778327
• Report Number: MW5152114
• 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: 02/23/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2024
• Patient Sequence Number: 1
• Treatment: CANE AND MEDICAL GRADE SHOES.; MORPHINE.
• Patient Outcome(s): Required Intervention; Life Threatening; Other
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White