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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. UNKNOWN REFOBACIN BONE CEMENT BONE CEMENT, ANTIBIOTIC

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BIOMET FRANCE S.A.R.L. UNKNOWN REFOBACIN BONE CEMENT BONE CEMENT, ANTIBIOTIC Back to Search Results
Model Number N/A
Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)
Patient Problem No Code Available (3191)
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. Ahmed nageeb mahmoud et. All "an analysis of one hundred forty-seven revisions at a mean of five years". The journal of arthroplasty (2016) 1e6. Concomitant medical products: item #unk, unknown stem, lot #unk; item #unk, unknown avantage cup, lot #unk; item #unk, unknown liner, lot #unk; item #unk, unknown head, lot #unk.

 
Event Description

Patient underwent hip revision procedure approximately 61 months post-implantation due to aseptic loosening, progressive cup loosening and migration. All components were revised.

 
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Brand NameUNKNOWN REFOBACIN BONE CEMENT
Type of DeviceBONE CEMENT, ANTIBIOTIC
Manufacturer (Section D)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR 26903
Manufacturer (Section G)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR 26903
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6335100
MDR Text Key67533837
Report Number3006946279-2017-00037
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeSW
PMA/PMN NumberPK150850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 02/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/16/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received01/18/2017
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: 02/16/2017 Patient Sequence Number: 1
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