MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. FEMORAL STEM AURA II HA / SIZE 6 RIGHT / CEMENTLESS / 542 / 12-14; PROTHESIS, HIP

Catalog Number P0126H06

Device Problem Insufficient Information (3190)

Patient Problem Hip Fracture (2349)

Event Date 07/11/2013

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) ((b)(6) registry - uk) : 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 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, 7 years after implantation.Only the stem was removed.

Manufacturer Narrative

- alize ii cup ha 48, reference (b)(4), batch 0000133397.- alize ii liner s48 d28, reference (b)(4), batch 00001411320.- ceramic femoral head d28/0mm 12/14, reference (b)(4), batch 928815.No x-ray provided, no surgical notes.Product not returned.Therefore, the reported event could not be confirmed.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.Within three years, no similar complaint has been recorded on aura ii hip ha coated right size 6, reference (b)(4), batch 0000128443 regarding revision due to bone fracture.According to available data, root cause of the event was unable to be determined.However, there is no evidence that the event is related to the product.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 has been reported that over data from njr (national joint registry - uk) : 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, 7 years after implantation.Only the stem was removed.

• Brand Name: FEMORAL STEM AURA II HA / SIZE 6 RIGHT / CEMENTLESS / 542 / 12-14
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 10008628
• MDR Text Key: 196779395
• Report Number: 3006946279-2020-00082
• 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: 09/16/2020

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: 11/30/2009
• Device Catalogue Number: P0126H06
• Device Lot Number: 0000128443
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/07/2020
• Initial Date FDA Received: 04/29/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASSOCIATED DEVICES LISTED IN H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR