MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCREW; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Loss of Osseointegration (2408)

Patient Problem Pain (1994)

Event Date 06/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00875705601 ¿ continuum cup ¿ 61774203.00877504002 ¿ biolox delta head ¿ 231975.00885101240 ¿ neutral liner ¿ unknown lot number.Reported event is confirmed by review of medical records and radiographs noting acetabular component spinning out of position and a fractured bone screw.Visual review of photographs identified the following : the products were covered in biodebris.A fragment of the fractured screw was protruding out of one of the screw holes.Dhr was unable to be reviewed as the lot number is unknown.The root cause is unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02618.

Event Description

It was reported that patient underwent a left hip revision approximately 9 years post implantation due to loosening of the acetuabular component and fracture of the screw.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: BONE SCREW
• 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: 10301538
• MDR Text Key: 199664889
• Report Number: 0001822565-2020-02619
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• 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
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 00625006535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2020
• Initial Date FDA Received: 07/21/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 70