MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. CMK HEAD 28MM/NL 0; PROTHESIS, HIP

Catalog Number P0201M28

Device Problem Insufficient Information (3190)

Patient Problem Hip Fracture (2349)

Event Date 12/23/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (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 has been reported that over data from (b)(6): review the performance of implants following a review of the data conducted in (b)(6) 2019 on aura ii, on 304 primaries surgeries, 33 have been revised during the first year postoperative.This complaint is related to revision due to periprosthetic fracture: it was reported that a patient underwent revision (hip, right) due to periprosthetic fracture, 4 years after implantation.The head and the stem were removed.

• Brand Name: CMK HEAD 28MM/NL 0
• Type of Device: PROTHESIS, HIP
• 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: 10012957
• MDR Text Key: 192003934
• Report Number: 3006946279-2020-00095
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• 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
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2010
• Device Catalogue Number: P0201M28
• Device Lot Number: 0000161641
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/07/2020
• Initial Date FDA Received: 04/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR