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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40 US BONE CEMENT, ANTIBIOTIC

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BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40 US BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 110034355
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032)
Event Type  Injury  
Manufacturer Narrative

(b)(4). The device will not be returned to the manufacturer as cement remains implanted. Therefore it will not be analyzed. The device manufacturing quality record indicates that the released product met all requirements to perform as intended. The review of the raw material certificate shows no non conformity or deviation. The investigation is in progress. Once the investigation has been completed, a follow-up mdr will be submitted. 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 patient underwent right total knee arthroplasty (b)(6) 2019. Subsequently, patient has had pain, difficulty walking (limps) and limited range of motion since her procedure. She had allergy testing and was told she is quite possibly allergic to the bone cement. She requested material composition for all devices to provide to her allergist.

 
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Brand NameREFOBACIN BONE CEMENT R 1X40 US
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 Key10709846
MDR Text Key212257367
Report Number3006946279-2020-00212
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK171540
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 10/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device Catalogue Number110034355
Device LOT Number818EAK2709
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/26/2018
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: 10/21/2020 Patient Sequence Number: 1
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