• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET GLOBAL SUPPLY CHAIN CENTER B.V. ZIMMER BIOMET OXFORD PARTIAL KNEE; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET GLOBAL SUPPLY CHAIN CENTER B.V. ZIMMER BIOMET OXFORD PARTIAL KNEE; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME Back to Search Results
Patient Problems Failure of Implant (1924); Pain (1994); Joint Laxity (4526)
Event Date 06/08/2022
Event Type  malfunction  
Event Description
I am notifying the fda of a failed (partial knee revision).I had a zimmer biomet oxford partial knee replacement on (b)(6) 2022.By october 2022.I was still not recovering well.I had more pain than i should have.The knee was unstable and giving out.I called the doctor's office and notified them of the instability and the knee giving out.The doctor said he would not order tests to see why i was having a problem until i met a one year recovery duration.He told me he thought the pain was coming from rsd/crps and to see a neurologist.After the one year recovery.He ordered bone scan and ct scan.The scans show the implant is misaligned and 6 mm lucency and a second opinion doctor confirmed it and said it might also be too big.It has been recommended by the operating surgeon and a second opinion surgeon that i have a revision.The operating surgeon is concerned about redoing the knee because of the severe pain i experienced for several months afterwards and he didn't think he could provide the anesthesia needed.The second opinion surgeon recommended that i have the revision done in an academic setting so that i could be provided anesthesia that would help control pain and to prevent complex regional pain syndrome.I finally found an expert in rsd/crps doctor and he said he didn't think i have rsd/crps at this time and that the device was causing my pain.But, he did recommend that i have revision in academic setting to prevent rsd/crps.Device information: my doctor will not give me this information!.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ZIMMER BIOMET OXFORD PARTIAL KNEE
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
Manufacturer (Section D)
BIOMET GLOBAL SUPPLY CHAIN CENTER B.V.
MDR Report Key18383726
MDR Text Key331346994
Report NumberMW5149465
Device Sequence Number1
Product Code NRA
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 12/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/21/2023
Patient Sequence Number1
Treatment
CALCIUM CITRATE.; COLLAGEN.; GABAPENTIN.; LEFT KNEE IMPLANT (FAILED WITHIN ONE YEAR OF IMPLANTATION).; LEVOTHYROXINE.; RIGHT HIP IMPLANT.; TERBINAFINE.; TUMERIC.; VITAMIN D.; VOLTAREN GEL.; WALKING STICK ( DUE TO FAILED KNEE IMPLANT).
Patient Age66 YR
Patient SexFemale
Patient Weight64 KG
Patient RaceWhite
-
-