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

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 12/06/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 ¿ refobacin bc r 1x40 us item:110034355 lot:g1222y34ab tibia trabecular metal two-peg porous fixed bearing left size d item:42530006701 lot:65261762 articular surface medial congruent (mc) left 10 mm height use with tibia sizes c-d/cr femur sizes 8-9 item:42512100510 lot:64603959 femur cemented cruciate retaining (cr) standard nitrided left size 8 item:42572606401 lot:65266287 nexgen complete knee solution, trabecular metal standard primary patella item:00587806532 lot:65019527 multiple mdr reports were filed for this event, please see associated reports: 3006946279-2024-00001.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent a revision surgery due to pain, approximately one (1) year four (4) months from initial left knee procedure.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).No product was returned or pictures provided; visual evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.Radiographs were provided and reviewed by a radiologist.The review identified a left total knee arthroplasty with osteopenia.No significant radiolucency to suggest loosening was found.No acute fracture was found neither.Mild femoral notching was noticed.It has been noticed that patient suffers from allergies to nickel and latex, however none of these two components are part of the cement composition.With the available information, a definitive root cause could not 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.

Event Description

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

• Brand Name: REFOBACIN BC 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: 18424225
• MDR Text Key: 331796759
• Report Number: 3006946279-2024-00002
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 0880304990197
• UDI-Public: (01)0880304990197(17)240831(10)H1202Y36CA
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 110034355
• Device Lot Number: H1202Y36CA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2021
• 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 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 136 KG