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 Problems Pain (1994); Joint Swelling (2356)

Event Date 09/15/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4).Report source, foreign ¿ event occurred in (b)(6).Combination product ¿ yes.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-04736.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 enrolled in a clinical study and underwent a revision approximately one and a half years post-implantation due to loosening below the tibia plateau.The patient also noted stress pain and swollenness.The tibial tray and femoral component were removed and replaced.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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 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: 6879237
• MDR Text Key: 86747619
• Report Number: 3006946279-2017-00158
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 4711500396
• Device Lot Number: 151AAE1408
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2012
• 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: BIOMET TIBIAL TRAY PN141235 LNJ2383944; VANGUARD BEARING PNEP-183462 LN620230; VANGUARD FEMORAL COMPONENT PN183033 LN095350
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 108