MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40-3; BONE CEMENT , ANTIBIOTIC

Catalog Number 3003940001-3

Device Problems Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Death (1802); Failure of Implant (1924); Unspecified Infection (1930)

Event Date 01/18/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).Unique identifier (udi) # (b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, (revision due to loosening).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that patient underwent revision due to loosening.

Manufacturer Narrative

(b)(4).The device will not be returned to the manufacturer.Therefore it will not be analyzed.Reserve sample from the same lot was evaluated.Testing was performed under standardized conditions and the sample tested showed no abnormal behavior.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.According to the available data, the exact root cause of the event cannot be determined.There is no evidence that the refobacin bone cement r was involved in the event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed.Zimmer biomet will continue to monitor for trends.

Event Description

It had been initially reported that the patient was revised due to loosening.Further investigation showed that the patient was admitted to the hospital with sepsis.During investigation for the reason of sepsis the surgeon found out that the patient had a hip implant, and assumed this could be the cause (the initial surgery was performed in different hospital).The surgeon decided to remove the implant in order to cure the sepsis.However, when the patient was revised, there was absolutely no indication that the implant could in any way contribute to the state of the patient (there was no signs of infection, loosening or other problems around the implant).The implant was removed and replaced with spacer (even though there was no evidence that the implant had any negative effect).The patient died two days after the revision due to sepsis.

• Brand Name: REFOBACIN BONE CEMENT R 1X40-3
• 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: 8365488
• MDR Text Key: 136978939
• Report Number: 3006946279-2019-00142
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04040029922569
• UDI-Public: (01)04040029922569
• 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
• Type of Report: Initial,Followup
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 3003940001-3
• Device Lot Number: 815AAK0709
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPTIVAC M, ITEM 4160; OPTIVAC M, ITEM 4160
• Patient Outcome(s): Death; Hospitalization; Required Intervention