MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AURA II HIP HA COATED LEFT SIZE 8; PROSTHESIS, HIP

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Hip Fracture (2349)

Event Date 10/10/2005

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 following a review of the data conducted by the national joint registry in march 2019 on aura ii cementless stem."aura ii cementless stem ¿ level 2 performance status in primary hip replacement", on 304 primaries surgeries, 33 had been revised.The patient underwent a revision due to bone fracture.The stem and the head have been removed.No other adverse events have been reported as a result of the malfunction.

Event Description

It was reported that following a review of the data conducted by the national joint registry in march 2019 on aura ii cementless stem "aura ii cementless stem ¿ level 2 performance status in primary hip replacement", on 304 primaries surgeries, 33 had been revised.This complaint is related to revision due to periprosthetic fracture stem : the patient underwent a revision of the left hip due to periprosthetic stem fracture, 1 month after implantation.The femoral stem and head were removed.No other adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.D11-associated products : 00-7255-052-28 0 degree tm natural cup id 28mm od 52mm batch : 56471359.164191 biolox forte modular ceramic head 28mm standard neck 12/14 taper batch : 928818.The product analysis can't be performed as the product was not returned the device manufacturing quality record indicate that the released product met all requirements to perform as intended.A complaint extract was done regarding revision due to bone fracture: 1 complaint (1 product), this one included, has been recorded on aura ii hip ha coated left size 8, reference p0125h08, from 01 january 2017 to 31 august 2020.1 complaint (1 product), this one included, has been recorded on aura ii hip ha coated left size 8, reference p0125h08, batch 0000147917.According to available data, root cause of the event was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: AURA II HIP HA COATED LEFT SIZE 8
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 10012904
• MDR Text Key: 191681493
• Report Number: 3006946279-2020-00098
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2010
• Device Model Number: N/A
• Device Catalogue Number: P0125H08
• Device Lot Number: 0000147917
• 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
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR