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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN CEMENT BONE CEMENT, ANTIBIOTIC

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BIOMET ORTHOPEDICS UNKNOWN CEMENT BONE CEMENT, ANTIBIOTIC Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Date 09/12/2016
Event Type  Injury  
Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. The following sections could not be completed with the limited information provided: brand name ¿ ni. Device code - ni. Device info - ni. Pma/510(k) number ¿ ni. Manufacture date ¿ ni. This report is number 2 of 2 mdrs filed for the same patient (reference 0001825034-2016-03864 / 03865).

 
Event Description

It was reported the patient underwent a revision procedure approximately thirteen years post-implantation due to loosening of the patella button. The surgeon noted the cement and patella button failed, which resulted in the patella button loosening. The polyethylene bearing and patella button were removed and replaced.

 
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Brand NameUNKNOWN CEMENT
Type of DeviceBONE CEMENT, ANTIBIOTIC
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key5987389
MDR Text Key55940409
Report Number0001825034-2016-03865
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 08/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 09/29/2016 Patient Sequence Number: 1
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