MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. ALIZE II STANDARD CUP TI HA SIZE 50 ACETABULUM PROSTHESIS

Catalog Number P0407P50

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 acetabular liner 28 x 50mm, reference p0502002, lot 0000246018. 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.

• Brand Name: ALIZE II STANDARD CUP TI HA SIZE 50
• Type of Device: ACETABULUM 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 Key: 10008584
• MDR Text Key: 190196681
• Report Number: 3006946279-2020-00073
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• 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 Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2011
• Device Catalogue Number: P0407P50
• Device Lot Number: 0000189521
• 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 Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2006
• 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