MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR MODULAR RADIAL STEM WITH SCREW; EXTREMITIES IMPLANTS

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)

Event Date 09/27/2023

Event Type  Injury  

Event Description

It was reported that a patient had an initial left elbow radial head replacement approximately 5 years ago.Subsequently, they were revised about a month ago due to disassociation.During the revision the head and screw stripped and flattened and there was metallosis throughout the joint.The head and screw were exchanged with an unknown component.The stem remains implanted.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).D6a - oct 2018.D10 - medical product: catalog #: 11-210044, explor 16x24 mm implant head, lot # 899710.H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02436.H3 other text : not returned.

Manufacturer Narrative

(b)(4).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

It was further reported that the patient was experiencing pain and loss of range of motion due to the disassociation.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and corrected information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02436-2.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right radial head replacement with disassociation of the head and screw from the stem as well as possible metallosis within the joint space.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 event information available at the time of this report.

• Brand Name: EXPLOR MODULAR RADIAL STEM WITH SCREW
• 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: 17985625
• MDR Text Key: 326276933
• Report Number: 0001825034-2023-02439
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00880304210479
• UDI-Public: (01)00880304210479(17)280525(10)029270
• 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,Followup,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• 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: 11-210064
• Device Lot Number: 029270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2018
• 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 Sex: Male