MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 12X24 MM IMPLANT HEAD; EXTREMITIES IMPLANTS

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 12/01/2023

Event Type  Injury  

Event Description

It was reported that a explore radial head implant disassociated from stem after 3 years of being implanted.The surgeon revised, taking the dissociated head out which had the screw in it.The stem was stable and stayed in.He cleaned the female threads checked to make sure the threads weren¿t striped by using a screw and torquing on it.Nothing was cross threaded or stripped.He then retrialed and implanted a new head with a new screw.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).D10 - medical product: catalog #: 11-210063, explor 8x28mm impl stem w/scr, lot # 037350.H3: product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: EXPLOR 12X24 MM IMPLANT HEAD
• Type of Device: EXTREMITIES IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18372720
• MDR Text Key: 331105527
• Report Number: 0001825034-2023-03047
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00880304438309
• UDI-Public: (01)00880304438309(17)291217(10)934480
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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: 11-210042
• Device Lot Number: 934480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2023
• Was Device Evaluated by Manufacturer?: No
• 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: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female