MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 2X40G; BONE CEMENT, ANTIBIOTIC

Catalog Number 3003940002

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 02/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign: event occurred in (b)(6).The device manufacturing quality record indicates that the released product met all requirements to perform as intended.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 the patient underwent a right hip revision 5 months post implantation due to acetabular loosening.Initial arthroplasty was performed on (b)(6)2019.Revision surgery was performed on (b)(6) 2020.No further patient consequences have been reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and corrected information.The product analysis can't be performed as the product was not returned.However, x-rays have been received and reviewed.It was noted that the cup is loose and osteolysis has been observed: "the acetabular implant is loosened and displaced as noted with abnormal vertical cup alignment.The femoral implant fit appears maintained as noted although the greater trochanter is a separate osseous fragment and the cerclage wire is fractured.There is no dislocation.Bone quality is markedly osteopenic.The acetabular implant is loose as noted.Abnormal proximal femoral radiolucencies reflect osteolysis.The requested angles can not be measured on the images but the displaced and loose acetabular implant is vertically oriented with a markedly elevated cup abduction angle.There is osteolysis as noted.The acetabular implant is loose and displaced." also, patient has rheumatoid arthritis and according to the surgeon, it is a contributing factor to the event "as there will be poor fixation in bone affected by rheumatoid disease." 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 loosening: 1 complaint, this one included, has been recorded on refobacin bone cement r 2x40g, reference (b)(4), from 1 january 2017 to 15 april 2020.1 complaint, this one included, has been recorded on refobacin bone cement r 2x40g, reference (b)(64, batch a735ca0210.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 the patient underwent a right hip revision one year and half post implantation due to acetabular loosening.Initial arthroplasty was performed on (b)(6) 2018.Revision surgery was performed on (b)(6) 2020.No further patient consequences have been reported.

• Brand Name: REFOBACIN BONE CEMENT R 2X40G
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 9817404
• MDR Text Key: 187914018
• Report Number: 3006946279-2020-00029
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 3003940002
• Device Lot Number: A735CA0210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention