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

Catalog Number 110034355

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will not be returned to the manufacturer.Therefore it will not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.With the available information, the exact root cause of the event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It has been reported that two batches of cement mixed following a knee revision.The cement never reached the "silky doughy" stage.It was still very tacky at 4 minutes, and every attempt to push it into the bone, both with fingers, and with spatula caused the cement to pull out of the bone.Then, the cement hardened in 10 minutes leaving a void behind the femur and additional cement had to be mixed an packed into the void.

Event Description

It has been reported that two batches of cement were mixed following a knee revision.The cement never reached the "silky doughy" stage.It was still very tacky at 4 minutes, and every attempt to push it into the bone, both with fingers, and with spatula caused the cement to pull out of the bone.Then, the cement hardened in 10 minutes leaving a void behind the femur and additional cement had to be mixed an packed into the void.No adverse patient clinical consequences were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The device will not be returned to the manufacturer.Therefore it will not be analyzed.A sample of the same lot number have been analyzed.The product did not show any unusual behavior during mixing, handling or setting.The reported behavior of the cement could not be reproduced.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.With the available information, the exact root cause of the event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

• 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
• MDR Report Key: 8357395
• MDR Text Key: 136862990
• Report Number: 3006946279-2019-00099
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 0880304990197
• UDI-Public: (01)0880304990197
• Combination Product (y/n): N
• PMA/PMN Number: K171540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 110034355
• Device Lot Number: 731BAE2909
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 05/29/2019
• Supplement Dates FDA Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1