MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BIOMET SCREW; BONE FIXATION

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital does not allow return of product.The investigation is in process.Once the investigation is completed, a follow up mdr will be submitted.Concomitant medical products: item # 110010265 g7 osseoti shell lot # 3873241, item # 110024464 g7 dual mobility liner lot # 994580.Hospital does not allow return of product as recorded by sales rep.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-00420, 00421, 00513.00514, 00515, 00516, 00517, 00518, 00519.

Event Description

It was reported that the patient underwent a revision surgery for disassociation less than thirty days post initial total hip replacement.Due to the patient's pre-existing condition, eight screws were used to implant the shell.However, the screws backed out of the shell, and pushed the liner out causing the disassociation.Due to the poor bone quality and failing health of the patient, all implants were removed.Attempts have been made, and no further information available.

Manufacturer Narrative

Upon review it has been determined that this report has been submitted under the wrong mfr#.This will be reported on mfr 0002648920-2018-00226.

• Brand Name: UNKNOWN BIOMET SCREW
• Type of Device: BONE FIXATION
• 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: 7228759
• MDR Text Key: 98597477
• Report Number: 0001825034-2018-00512
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR