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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN PLUS BONE CEMENT 40 BONE CEMENT, ANTIBIOTIC

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BIOMET FRANCE S.A.R.L. REFOBACIN PLUS BONE CEMENT 40 BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 4020830401
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Pain (1994)
Event Date 03/08/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). This medwatch report is associated to the medwatch report 0001822565- 2018 -01987 (zimmer biomet reference (b)(4)) related to the same revision surgery concerning a tibial component precoat left medial/right lateral size 2, catalog # 00584200201, lot # 63270273. Report source- foreign. The event occurred in (b)(6). The device was not returned, therefore no product evaluation has been performed. Device history record (dhr) was reviewed and no discrepancies were found. Investigation results concluded that the product is conform and the root cause is undertemined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

 
Event Description

It was reported that a patient underwent initial knee arthroplasty on (b)(6) 2017. The patient was revised on (b)(6) 2018 to address pain and tibial loosening and/or subsidence.

 
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Brand NameREFOBACIN PLUS BONE CEMENT 40
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
helene bataille
plateau de lautagne bp75
valence cedex 26903
FR   26903
0334757591
MDR Report Key7403580
MDR Text Key104592289
Report Number3006946279-2018-00139
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberPK150850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 04/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2019
Device Catalogue Number4020830401
Device LOT NumberA612DF0606
OTHER Device ID Number(01) 07350023774437
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 Received03/08/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/29/2016
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: 04/06/2018 Patient Sequence Number: 1
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