MAUDE Adverse Event Report: EXPLOR IMPLANT LOCKING SCREW; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 07/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: explor 12x22mm implant head cat#11-210032 lot#419620.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02294.

Event Description

It was reported that a patient underwent a revision procedure approximately 5 months post implantation due to disassociation of the modularhead and locking screw.Head and screw were both replaced but the stem could not be removed.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left elbow radial head replacement with evidence of a screw within the elbow joint.Oblique appearance of the radial head replacement could indicate loosening.The screw was not returned therefore no analysis will be performed.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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 is available at the time of this report.

• Brand Name: EXPLOR IMPLANT LOCKING SCREW
• Type of Device: PROSTHESIS, ELBOW
• MDR Report Key: 12335841
• MDR Text Key: 267040344
• Report Number: 0001825034-2021-02295
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2021
• 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
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 104