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

Catalog Number 110034355

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

(b)(4). The device will not be returned to the manufacturer as cement remains implanted. Therefore it will not be analyzed. The device manufacturing quality record indicates that the released product met all requirements to perform as intended. The review of the raw material certificate shows no non conformity or deviation. 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 patient underwent right total knee arthroplasty (b)(6) 2019. Subsequently, patient has had pain, difficulty walking (limps) and limited range of motion since her procedure. She had allergy testing and was told she is quite possibly allergic to the bone cement. She requested material composition for all devices to provide to her allergist.

• Brand Name: REFOBACIN BONE CEMENT R 1X40 US
• Type of Device: BONE CEMENT, ANTIBIOTIC
• 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: 10709846
• MDR Text Key: 212257367
• Report Number: 3006946279-2020-00212
• Device Sequence Number: 1
• Product Code: MBB
• 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: OTHER

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/21/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/21/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device Catalogue Number: 110034355
• Device LOT Number: 818EAK2709
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 07/26/2018
• 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 TREATMENT DATA

Date Received: 10/21/2020 Patient Sequence Number: 1