FDA Adverse Event Malfunction Summary report: N

BIOMET BONE CEMENT V

MDR report key: 6522353 · Received April 26, 2017

Report

Report Number: 3006946279-2017-00085
Event Type: Malfunction
Date Received: April 26, 2017
Report Date: July 31, 2017
Manufacturer: BIOMET FRANCE S.A.R.L.
Product Code: MBB
PMA / PMN Number: PSEE H10
Removal / Correction Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). (B)(6). ZIMMER BIOMET FRANCE AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET FRANCE MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K150850. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

REPORTED EVENT WAS UNABLE TO BE CONFIRMED. THE PRODUCT RELATED TO THE EVENT WAS NOT RETURNED; HOWEVER, A SAMPLE FROM A DIFFERENT RETAINED LOT WAS EVALUATED. THE RETAINED SAMPLE SHOWED A SLOWER SETTING TIME, BUT DID NOT CONFIRM THE EVENT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE LOT NUMBER OF THE PRODUCT INVOLVED IN THE EVENT AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PROCEDURE, THE CEMENT WAS TOO LIQUID AND TOOK A LONG TIME TO OBTAIN THE CORRECT VISCOSITY. NO PATIENT CONSEQUENCES WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
304037	BIOMET BONE CEMENT V	BONE CEMENT, ANTIBIOTIC	MBB	BIOMET FRANCE S.A.R.L.	N/A	A624AF0606

Patients

Seq	Age	Sex	Outcome	Treatment
1