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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET, INC. TIBIAL INSERT; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/PO
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BIOMET, INC. TIBIAL INSERT; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/PO Back to Search Results
Catalog Number 159569
Patient Problems Pain (1994); Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577)
Event Date 04/17/2019
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2019, the patient had swelling and it was loose in knee.Patient had x-rays and it was confirmed that it was loose.Not infected had bloodwork done to make sure.Patient was taking naproxen 500 mg for the swelling and to help with the pain and meds were prescribed by surgeon.Patient was also taking methocarbamol for muscle spasms 500 mg.Patient ice most evenings for swelling and pain.Patient had a hard time walking.This was a full right knee replacement performed by surgeon at hospital.Patient had since retired.So patient saw another doctor local just for x-rays and to get some meds.Patient should not have another surgery so soon and be in this kind of pain.Reference reports: mw5144586, mw5144587, mw5144588.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
TIBIAL INSERT
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/PO
Manufacturer (Section D)
BIOMET, INC.
MDR Report Key17557101
MDR Text Key321401284
Report NumberMW5144589
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 04/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue Number159569
Device Lot Number2560161
Patient Sequence Number1
Treatment
BONE CEMENT.; FEMORAL COMPONENT. ; ICE PACK.; METHOCARBAMOL 500MG.; NAPROXEN 500MG.; TIBIAL TRAY.
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