MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40 US

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 03/25/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: tibia cemented 5 degree stemmed right size c; item# 42532006402; lot# 64884536; femur cemented cruciate retaining (cr) narrow right size 5; item# 42502005802; lot# 63717984; articular surface medial congruent (mc) right 10 mm height use with tibia sizes c-d/cr; femur sizes 4-5; item# 42522100310; lot# 64557869; stem extension tapered cemented 14 mm diameter +30 mm length; item# 42557000114; lot# 65264231; all poly patella cemented 29 mm diameter; item# 42540000029; lot# 65134509; refobacin bc r 1x40 us; item# 110034355; lot# az47ba1511.The complainant has not yet indicated whether the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a right knee arthroplasty revision to address a deep, staphylococcus hominis and staphylococcus epidermidis infection seventeen days post-operatively.Attempts have been made, however, no additional information is available at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Product was not returned or pictures not provided.Device evaluation could not be performed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.The review of the sterilization certificate indicates that the products were sterilized according to the specification.This device is used for treatment.Review of medical records can't be performed as they were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: REFOBACIN BONE CEMENT R 1X40 US
• Type of Device: BONE CEMENT
• 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: 14574442
• MDR Text Key: 293266779
• Report Number: 3006946279-2022-00051
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 00880304990197
• UDI-Public: (01)00880304990197(17)230430(10)K1903Z22CA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 110034355
• Device Lot Number: K1903Z22CA
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female