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U.S. Department of Health and Human Services

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

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BIOMET FRANCE S.A.R.L. OPTIPAC REFOBACIN PLUS BONE CEMENT BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number OPTIPAC BONE CEMENT PLUS
Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Naturally Worn (2988)
Patient Problem Osteolysis (2377)
Event Date 01/31/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). (b)(6). Implant date: 2005. Customer has indicated that the product will not be returned because product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were previously filled for (b)(4): 0001825034 -2018 -01577, 0001825034-2018-01579, 0001825034-2018-01324, 0001825034 -2018 -02607.

 
Event Description

It was reported that the patient underwent an initial knee arthroplasty in (b)(6) 2005, using optipac refobacin plus bone cement. Subsequently, the patient was revised on (b)(6) 2018 due to fracture of the implant, loosening, osteolysis, and wear. The tibial base plate is broken in situ, a significant delamination process was recognized. It was reported an aseptic loosening on the femoral implant and in the ventral area of the tibial base plate. This complaint is related to the complaint (b)(4) recorded on the following products: vngd cr tib brg 14x79/83 catalog # 183464 lot # not communicated, maxim ilok ana pri fml 75 rt catalog # 140014 lot # not communicated, biomet tibial component, catalog #141216 lot# not communicated, biomet finned pri stem 40 mm, catalog # 141314 lot # 789370.

 
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Brand NameOPTIPAC REFOBACIN PLUS 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
hélène bataille
plateau de lautagne bp75
valence 26903
FR   26903
0334757591
MDR Report Key7468320
MDR Text Key106731885
Report Number3006946279-2018-00148
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeAU
PMA/PMN NumberPK150850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberOPTIPAC BONE CEMENT PLUS
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 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: 04/27/2018 Patient Sequence Number: 1
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