MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN PLUS BONE CEMENT 40; ORTHOPAEDIC CEMENT, MEDICATED

Catalog Number 3020830401

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Infection (1930)

Event Date 10/15/2021

Event Type  Injury  

Manufacturer Narrative

This is a combination product (b)(4).Report source, foreign and health professional - event occurred in (b)(6).List of associated products : item 0059620421 _ articular surface with insert and locking screw use with lps/lps-flex 51 or 52 suffix femoralssize gh 17 mm height _ batch : 62920054; item 4020830401_ refobacin plus bone cement _batch ag10dl0103.The device manufacturing quality record indicate 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: a patient underwent a knee arthroplasty on (b)(6) 11, 2017.Patient was revised due to infection on (b)(6) 2021.Patient involvement- revision surgery.

Event Description

It was reported that a patient underwent a knee arthroplasty.Patient was revised due to infection.No further adverse event was reported.

Manufacturer Narrative

This is a combination product: (b)(4).This follow-up is to relay additional information.No contributing conditions have been reported.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 a knee arthroplasty on (b)(6) 2017.Patient was revised due to infection on (b)(6) 2021.

Manufacturer Narrative

(b)(4).This follow-up is to relay additional information.X-rays shows the prosthesis implanted in the knee and review assessed that implant placement was well performed.So the most probable cause of a revision could not be related to implant placement, but indeed to infection.1 complaint on medical: revision was recorded on the batch since ever, and 1 complaint on medical: revision was recorded on the reference from (b)(6) 2018 to (b)(6) 2022.2 complaints on medical: infection was recorded on the batch since ever, and 3 complaints on medical: revision were recorded on the reference from (b)(6), 2018 to (b)(6), 2022.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: REFOBACIN PLUS BONE CEMENT 40
• Type of Device: ORTHOPAEDIC CEMENT, MEDICATED
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12777639
• MDR Text Key: 280508495
• Report Number: 3006946279-2021-00195
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 3020830401
• Device Lot Number: A610DL0103
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 FOR ASSOCIATEDPRODUCTS.
• Patient Outcome(s): Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male