MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.5MM POLYAXIAL SCREW FT 25MM; SCREW, FIXATION, BONE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 01/30/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034 - 2019 - 02617, 0001825034 - 2019 - 02619, 0001825034 - 2019 - 02620, 0001825034 - 2019 - 02621, 0001825034 - 2019 - 02622, 0001825034 - 2019 - 02623, 0001825034 - 2019 - 02625, 0001825034 - 2019 - 02626, 0001825034- 2019 - 02627.Concomitant associated device(s): product, lot or serial, description, primary di: 815355070, lot: unknown, 5.5mm polyaxial screw ft 70mm, (b)(4), 815355080 , lot: unknown, 5.5mm polyaxial screw ft 80mm, (b)(4),  815355060, lot: unknown, 5.5mm polyaxial screw ft 60mm, (b)(4),  815355025, lot: unknown 5.5mm polyaxial screw ft 25mm, (b)(4),  815308075, lot: unknown, 8.0mm cann locking ft 75mm, (b)(4), 815045540, lot: unknown, 4.5 locking shaft screw 40mm, (b)(4),  815045536, lot: unknown, 4.5 locking shaft screw 36mm, (b)(4),  815045514, lot: unknown, 4.5 locking shaft screw 14mm, (b)(4),  815745036, lot: unknown, 4.5 x 36mm cortical screw ft, (b)(4),  814131106 , lot: 666670, femoral plate 6 hole left, (b)(4).  the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the patient expired; however, cause of death was not listed.There are no allegations of device involvement.No further information is available at the time of this reporting.

Manufacturer Narrative

Upon reassessment of the reported event based on the additional information received, it was determined that the cause of death was due to anorexia, poor po intake ¿ patient was not eating or drinking enough to support/sustain life and was not due to the medical devices.Hence the initial report needs to be voided.

Event Description

It was further reported upon review the patient expired due to natural causes, and the devices were not alleged to have contributed, according to the medical documentation.Cause of death was: anorexia, poor po intake ¿ patient was not eating or drinking enough to support/sustain life.Significant conditions contributing to but not causing death: hyponatremia, gerd, copd, anxiety.

Manufacturer Narrative

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.Lot identification is necessary for review of device history records, lot identification was not provided 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 information is available at the time of this reporting.

• Brand Name: 5.5MM POLYAXIAL SCREW FT 25MM
• Type of Device: SCREW, FIXATION, BONE
• 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: 8718336
• MDR Text Key: 148657581
• Report Number: 0001825034-2019-02624
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• 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: 815355025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2019
• 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
• Patient Outcome(s): Death
• Patient Age: 91 YR