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

Model Number N/A

Device Problems Unintended System Motion (1430); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 01/16/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - associated products; femoral stem low demand/fracture cemented 12/14 neck taper rasp 14 or 15 size 14 135 mm stem length , item# 00783301400 , lot# 64874473.Endo femoral head 12 / 14 taper , item# 00781805100 , lot# 65499504.Distal centralizer 12 mm o.D., item# 00785901200, lot# 65509002.Endo femoral head adaptor 12 / 14 taper plus 7.0 mm neck length item# 00781809900 , lot# 65366691.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that cemented stem was dislodged from cement mantle during closed reduction of dislocation approximately 1-month post-implantation.Patient was revised.Due diligence is in progress for this complaint; to date no additional information.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Device used for treatment.Medical records were not provided.With the available information, a definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: REFOBACIN BC R 1X40 US
• Type of Device: BONE CEMENT
• 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: 16377962
• MDR Text Key: 309553875
• Report Number: 3006946279-2023-00013
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 00880304990197
• UDI-Public: (01)00880304990197(17)241130(10)Y49AAA0309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110034355
• Device Lot Number: Y49AAA0309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male