MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 60 BIOMET BC R; BONE CEMENT, ANTIBIOTIC

Catalog Number 110035375

Device Problem Biocompatibility (2886)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/23/2023

Event Type  Death  

Manufacturer Narrative

(b)(4).G2 - foreign: japan.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 when the surgeon placed the bone cement into the femoral cavity, the patient's blood pressure dropped rapidly.The patient was treated in the intensive care unit however, the patient died the same day.It is unknown if the patient's death was related to the device.Due diligence is completed for this complaint; to date whatever additional information received has been captured.

Manufacturer Narrative

(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.An iso-setting test has been performed.A retain sample of same batch has been tested in the laboratory under standardized conditions.No unusual cement paste temperature and hardening time has been noticed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.A review of the raw material certificate confirmed no abnormalities or deviations.A review of the sterilization certificate confirmed no abnormalities or deviations.Device is used for treatment.Medical records were not provided.With the available information, a definitive root cause cannot be determined.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.

Event Description

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

• Brand Name: OPTIPAC 60 BIOMET BC R
• 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: 17875660
• MDR Text Key: 324971931
• Report Number: 3006946279-2023-00079
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04547038258059
• UDI-Public: (01)04547038258059(17)240630(10)AW01AK2513
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 110035375
• Device Lot Number: AW01AK2513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• 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): Death
• Patient Age: 91 YR
• Patient Sex: Female