MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BRANDT LEFT TRIFLANGE SZ 24; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888)

Event Date 08/27/2021

Event Type  Death  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02951.0001825034 - 2021 - 02952.0001825034 - 2021 - 02953.0001825034 - 2021 - 02954.0001825034 - 2021 - 02955.0001825034 - 2021 - 02956.0001825034 - 2021 - 02957.0001825034 - 2021 - 02958.0001825034 - 2021 - 02959.

Event Description

It was reported the patient underwent left tha due to femoral neck fracture.Patient was revised two days later due to an iatrogenic acetabular fracture.The patient underwent a second revision 4 months later due to pain and instability with placement of a custom cage and constrained liner.During the revision, bleeding was noted from the sciatic notch region with subsequent ekg changes.The bleeding was controlled with hemostatic agents and packing while a vascular surgeon was consulted and confirmed no apparent vascular injury had taken place.The patient was resuscitated, the femoral components removed, and the wound closed.The patient was taken to the critical care unit intubated.The patient expired the next day.Cause of death has not been provided.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.It was reported a patient experienced cardiac arrest and expired following revision hip surgery.Revision notes indicate that the surgeon removed the existing acetabular cup and cemented liner without complications.The screws that held the cup in place would not back out, and were cut with a bur.Without re-reaming, he then implanted the custom cage and screws and secured the acetabular liner.He then turned his attention to the femur and implanted the final components after trailing.While attempting to reduce the hip, brisk bleeding was noted from the greater sciatic notch region of the pelvis.This was packed with laps until hemostatic agents were available.It was during this time (approximately 3 hours into surgery) that anesthesia notified the surgeon of a drop in the patient¿s blood pressure and detection of the ekg rhythm was lost.The hip was left dislocated, and the patient was flipped to supine position for chest compressions and resuscitative measures.Arterial pulses and spontaneous eye opening returned while the surgeon discussed the case with a vascular surgeon.Arterial and venous studies showed no vascular injury was present.The patient was stable for surgery completion and closure.Rather than risking destabilization by reducing the hip, the surgeon removed the implanted femoral components.No bleeding was noted, and no hemostatic agents were necessary.Total blood loss for the procedure was estimated to be approximately 1l which is not an unexpected amount for a revision this intense.The patient was transferred to the critical care unit intubated.The patient expired the next day.The cause of expiration has not yet been reported.Furthermore, it was reported that the patient cardiovascularly deteriorated after a bleed was noted from the greater sciatic notch region leading to resuscitative measures and chest compressions.This region of the pelvis is where the superior gluteal vein and artery pass through the hip and into the femur; however, the vascular surgeon did not identify a vascular injury after the bleeding was occluded.The patient stabilized, and pressures returned.The patient expired the next day relating to perioperative complications.The only pre-existing patient risk factor/comorbidity was that the patient was on chronic antihypertensive medications which may have contributed to the sensitivity in blood pressure changes during the procedure.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device history records will not be performed.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: BRANDT LEFT TRIFLANGE SZ 24
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12697327
• MDR Text Key: 278618869
• Report Number: 0001825034-2021-02950
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CUSTOM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PM0003641
• Device Lot Number: 387610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOMET LINER CAT#11-107323 LOT#838200.
• Patient Outcome(s): Hospitalization; Required Intervention; Death
• Patient Sex: Female
• Patient Weight: 63 KG