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

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Combination product ¿ yes.Concomitant medical product- zimmer persona femoral cemented ps standard left size 9, catalog #: 42500606601, lot #: 62978669; zimmer persona articular surface fixed bearing ps left 12 mm height, catalog #: 42511400712, lot # 62857173.

Event Description

It was reported that following a total knee arthroplasty, the patient was revised due to tibial loosening.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: REFOBACIN BONE CEMENT R
• 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: 6541450
• MDR Text Key: 74322270
• Report Number: 3006946279-2017-00088
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 4721502084-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 55