MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR IMPLANT LOCKING SCREW; ROD, FIXATION

Model Number N/A

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a patient underwent a procedure and was revised eight years post implantation due to migration of screw from explore radial head/stem.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Upon receipt of additional information, it has been determined that this device is part of the stem system.The stem will be reported.The screw should not have been reported individually.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of additional information, it has been determined that this device is part of the stem system.The stem will be reported.The screw should not have been reported individually.The initial report was forwarded in error and should be voided.

• Brand Name: EXPLOR IMPLANT LOCKING SCREW
• Type of Device: ROD, 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: 12300936
• MDR Text Key: 265816346
• Report Number: 0001825034-2021-02354
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051385
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• 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: 11-210099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2021
• 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: 11-210031 10X22 EXPLOR HEAD B342980; 11-210031 10X22 EXPLOR HEAD B342980
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male