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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Ahmed nageeb mahmoud et.All "an analysis of one hundred forty-seven revisions at a mean of five years".The journal of arthroplasty (2016) 1e6.Concomitant products: item #unk, unknown stem, lot #unk.Item #unk, unknown cup, lot #unk.Item #unk, unknown liner, lot #unk.Item #unk, unknown head, lot #unk.

Event Description

It was reported that a patient underwent hip revision procedure approximately 14 months post-implantation due to marked osteolysis, aseptic loosening, cup migration and protrusion.All acetabular components were revised.

• Brand Name: UNKNOWN REFOBACIN BONE CEMENT
• 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: 6335098
• MDR Text Key: 67534009
• Report Number: 3006946279-2017-00038
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2017
• 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