MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AVANTAGE CEMENTLESS ACETABULAR SHELL 52MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Hip Fracture (2349); Joint Dislocation (2374)

Event Date 06/23/2015

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 was reported that following a review of the data conducted by the national joint registry in (b)(6) 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 dislocation and fracture.The acetabular cup has been 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 : p0561052 avantage uhmwpe insert 52/28 batch : 0000132456.P0206l28 co cr modular head 28mm long batch : 0000118514.P0126y04 aura ii total ha coated right size 4 batch : 0000088898.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 dislocation and bone fracture: 1 complaint (1 product), this one included, has been recorded on avantage cementless acetabular shell 52mm, reference p0460052, from 01 january 2017 to 28 august 2020.1 complaint (1 product), this one included, has been recorded on avantage cementless acetabular shell 52mm, reference p0460052, batch 0000125323.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.

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 disclocation and bone fracture: the patient underwent a revision of the hip due to dislocation and bone fracture, 11 years after implantation.The acetabular cup were removed.No other adverse events have been reported as a result of the malfunction.

• Brand Name: AVANTAGE CEMENTLESS ACETABULAR SHELL 52MM
• 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: 10012895
• MDR Text Key: 189980172
• Report Number: 3006946279-2020-00096
• 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: 09/25/2020

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: 09/01/2009
• Device Model Number: N/A
• Device Catalogue Number: P0460052
• Device Lot Number: 0000125323
• 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: 09/25/2020
• 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: 70 YR