MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK EXPLOR RADIAL HEAD; PROSTHESIS, ELBOW

Device Problems Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Information (3190)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.This mdr was previously reported on 0001822565-2020-01008.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02245.

Event Description

It was reported that a patient underwent an elbow arthroplasty on an unknown date.Subsequently patient was revised approximately 7 years later due to the screw (from explor stem) and explor radial head disengaging.Sales rep stated the procedure took about 30 minutes longer to remove the screw from the arm.New screw and head were implanted.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.Additional information was provided.An unknown screw and unknown head was returned for evaluation.Visual inspection identified scratches on the devices.A slight damages on the threads of the screw were visible.No other evaluations can be made as the device details are unknown.Additional information does not change the root cause of the previous investigation.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: UNK EXPLOR RADIAL HEAD
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10127980
• MDR Text Key: 194318239
• Report Number: 0001825034-2020-02246
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• 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: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK EXPLOR RADIAL STEM CAT#NI LOT#NI; UNK EXPLOR RADIAL STEM CAT#NI LOT#NI
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 YR