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.

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.This event was reported through njr (national joint registry uk) report: review the performance of implants following a review of the data conducted in march 2019 on aura ii : on 304 primaries surgeries, 33 have been revised.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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 infection: 1 complaint (1 product), this one included, has been recorded on alize ii standard cup ti ha size 50, reference: (b)(4), from 1 january 2017 to 1 july 2020.1 complaint (1 product), this one included, has been recorded on alize ii standard cup ti ha size 50, reference: p0407p50, batch: 0000189521.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: 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
• 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
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• 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: Lay User/Patient
• Device Expiration Date: 04/30/2011
• Device Catalogue Number: P0407P50
• Device Lot Number: 0000189521
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR