MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 6X24MM IMPL STEM W/SCR; PROSTHESIS, ELBOW

Catalog Number 11-210061

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 reported that patient underwent left elbow procedure on an unknown date 12 years ago.Subsequently, patient was revised 1 month ago due to unknown reasons.Patient was converted to total elbow.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d6; d11; g4; g7; h1; h2; h3; h4; h6.Corrected: d4.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02669.D4: udi should be blank as the udi number previously reported was not active at the time this device was manufactured.D11: part# 11-210045, lot# 949220.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.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 6X24MM IMPL STEM W/SCR
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9726391
• MDR Text Key: 189170012
• Report Number: 0001825034-2020-00740
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00880304210448
• UDI-Public: (01)00880304210448
• Combination Product (y/n): N
• PMA/PMN Number: K040611
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 11-210061
• Device Lot Number: 479850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10.
• Patient Outcome(s): Hospitalization; Required Intervention