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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET/ZIMMER HIP IMPLANT PROSTHESIS HIP

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BIOMET/ZIMMER HIP IMPLANT PROSTHESIS HIP Back to Search Results
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Muscle Spasm(s) (1966); Pain (1994); Numbness (2415); Ambulation Difficulties (2544)
Event Date 11/17/2015
Event Type  Injury  
Event Description
Reporter alleges she had a biomet hip implant on (b)(6) 2011 and 11 days after surgery, the device dislocated and had to be popped back in the socket. Two years ago, she started experiencing pain and consulted a pain dr and was put on percocet and has been on it since. She advises the pain has gotten worse and caused her to limp and experienced ambulation difficulties. Reporter also mentions experiencing muscle spasm, muscle damage and numbness from hip down to her toes. She also alleges the implant tried to dislocate twice recently. Reporter will call back with info on model number and lot number.
 
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Brand NameHIP IMPLANT
Type of DevicePROSTHESIS HIP
Manufacturer (Section D)
BIOMET/ZIMMER
MDR Report Key7048278
MDR Text Key92641012
Report NumberMW5073429
Device Sequence Number1
Product Code KWA
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 11/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/20/2017 Patient Sequence Number: 1
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