MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AURA II HIP HA COATED LEFT SIZE 5 HIP FEMUR PROSTHESIS

Catalog Number P0125H05

Device Problems Fracture (1260); No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); No Information (3190)

Event Date 12/23/2004

Event Type  Injury  

Manufacturer Narrative

(b)(4). 0 degree tm natural cup id 28mm od 48mm , reference 00-7255-048-28, lot 56462484. Zr modular 5 degree 42 taper 28mm std, reference 164126, lot 772841. 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 periprosthetic bone fracture 5 months after implantation. No additional patient consequences were reported.

• Brand Name: AURA II HIP HA COATED LEFT SIZE 5
• Type of Device: HIP FEMUR 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: 10008514
• MDR Text Key: 191693442
• Report Number: 3006946279-2020-00065
• 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: 03/31/2009
• Device Catalogue Number: P0125H05
• Device Lot Number: 0000107650
• 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: 12/05/2002
• 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