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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: J&J - DEPUY ORTHOPAEDICS, INC CEMENT BONE 40GM HIGH VISCOSITY RADIOPAQUE LONG SET TIME MANUAL APPLICATION GENT; BONE CEMENT, ANTIBIOTIC
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J&J - DEPUY ORTHOPAEDICS, INC CEMENT BONE 40GM HIGH VISCOSITY RADIOPAQUE LONG SET TIME MANUAL APPLICATION GENT; BONE CEMENT, ANTIBIOTIC Back to Search Results
Model Number 5450-35-500
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Failure of Implant (1924); Nerve Damage (1979); Pain (1994); Swelling/ Edema (4577)
Event Date 03/20/2017
Event Type  Injury  
Event Description
Had arthritis and saw an orthopedic surgeon.He implanted an attune l knee prothesis.From day 1 i had problems.Severe pain; swelling and even the physical therapist relayed symptoms unusual.I finally had ct done and it showed debonding of prothesis and the original surgeon relayed he does not do revisions i finally found an excellent ortho doctor w/ (b)(6), and he saw results of ct and he replaced the attune device w/ a stryker device.But in interim of follow up from 1st surgery implant of attune device, i had additional surgery for left knee neuroma; then still had issues and swelling.Recently i had the peroneal nerve left knee decompressed by same surgeon who did the revision: dr.(b)(6).The original surgeon and his colleague he sent me to treat me as a hysterical female.Ps i am an rn in my 60's so i know my body very well, and i knew the severe pain i was feeling was not normal.Even dr (b)(6), the original surgeon, his own therapist had admitted to met the pain and symptoms i was having were very abnormal.
 
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Brand Name
CEMENT BONE 40GM HIGH VISCOSITY RADIOPAQUE LONG SET TIME MANUAL APPLICATION GENT
Type of Device
BONE CEMENT, ANTIBIOTIC
Manufacturer (Section D)
J&J - DEPUY ORTHOPAEDICS, INC
MDR Report Key15789215
MDR Text Key303679862
Report NumberMW5113219
Device Sequence Number4
Product Code MBB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/08/2022
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received11/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number5450-35-500
Device Catalogue Number545035500
Device Lot Number8241042
Patient Sequence Number1
Treatment
ACEYTL L- CARNITINE 500MG BID ; AMOXICILLIN 500MG (4) TABS PRIOR TO DENTAL PROCEDURES; ASA 81MG OD; B COMPLEX OD; BENADRYL 50MG HS ; COLCRYS 0.3MG OD; DICLOFENAC 3% PATCH TO LOWER BACK Q12H; DULOXETINE HCL DR 60MG BID; FLAXSEED OIL 1000MG OD; FOLIC ACID 800MG OD; LASIX 40MG OD; LIDOCAINE PATCH 5% BILAERAL KNEES Q12 H PRN ; LIPITOR 40MG HS; LISINOPRIL 5MG OD; MELATONIN 12MG HS; MG 250MG OD; NORVASC 5MG OD; PRESERVISION 1 TAB BID; ROBAXIN 750MG TID PRN ; TIZANIDINE 4MG 2 TABS FOR MUSCLE SPASM/ SLEEP ; TRAMADOL 50 MG PRN; TRULICITY 1.5MG ONCE/WK ON WED; TYLENOL 325MA 2 TABS PRN ; ULORIC 40MG OD; VENTOLIN HFA2 PUFFS PRN; VIT E 4001U OD; VITAMIN C 1000MG OD
Patient Outcome(s) Other;
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