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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. ALIZE ACETABULAR LINER 28 X 50MM ACETABULUM PROSTHESIS

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BIOMET FRANCE S.A.R.L. ALIZE ACETABULAR LINER 28 X 50MM ACETABULUM PROSTHESIS Back to Search Results
Catalog Number P0502002
Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 07/09/2009
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: biolox forte modular ceramic head 28mm-3. 5mm neck 12/14 taper, reference 164190, lot 1147459. Alize ii standard cup ti ha size 50, reference p0407p50, lot 0000189521. Aura ii hip ha coated left size 5, reference p0125h05, lot 0000137042. Foreign report source: (b)(6). 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 a patient underwent revision (hip, left) due to infection, 2 years and a half after implantation. No additional patient consequences were reported.
 
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Brand NameALIZE ACETABULAR LINER 28 X 50MM
Type of DeviceACETABULUM PROSTHESIS
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 Key10008611
MDR Text Key193060330
Report Number3006946279-2020-00074
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2012
Device Catalogue NumberP0502002
Device Lot Number0000246018
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2007
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: 04/29/2020 Patient Sequence Number: 1
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