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U.S. Department of Health and Human Services

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

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BIOMET FRANCE S.A.R.L. OPTIPAC BONE CEMENT, ANTIBIOTIC Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Device not returned because implanted.

 
Event Description

It was reported by the journal article ( published online : 9 may 2016) referenced below that a femoral loosening without revision occurred after a unicompartmental knee arthroplasty (uka) using a oxford implant. The aim of this article is to compare the cemented oxford uka and the cementless oxford uka. In this study, oxford implant and optipac products were used. Journal article reference : " cementless versus cemented oxford unicompartmental knee arthroplasty : early results of a non-designer user group", b. Kerens,mgm schotanus and al, european society of sports traumatology,knee surgery, arthroscopy ( esska), 2016 (7 pages).

 
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Brand NameOPTIPAC
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
hélène bataille
plateau de lautagne bp75
valence 26903
FR   26903
0334757591
MDR Report Key7206084
MDR Text Key97758614
Report Number3006946279-2018-00017
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/17/2019
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

Patient TREATMENT DATA
Date Received: 01/19/2018 Patient Sequence Number: 1
Treatment
OXFORD UNICOMPARTIMENTAL
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