MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 8X28MM IMPLANT STEM W/SCREW; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 04/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 11-210043, explor 14x24 mm implant head, 576380.Customer has been indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product location unknown.

Event Description

It was reported that a patient underwent an initial elbow procedure.Subsequently, the patient was revised due to loosening.During the revision surgery, the surgeon noticed that the locking screw was extremely loose.The head and locking screw were revised.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Stem remains implanted in the patient, however the screw subcomponent of this device was explanted, as it had loosened.The reported event cannot be confirmed with the information provided.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.X-ray review identified: there was a sizable gap between the proximal edge of the native radius and the support metallic base of the radial head component.Otherwise the hardware appeared intact on all of the provided images.No periprosthetic lucency can be appreciated and the bones demonstrate no fracture, dislocation, or abnormal mineralization and no joint effusion seen.The event of screw loosening was not confirmed from the x-rays.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: EXPLOR 8X28MM IMPLANT STEM W/SCREW
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6995976
• MDR Text Key: 90868684
• Report Number: 0001825034-2017-09798
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 11-210063
• Device Lot Number: 499670
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2013
• 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 Age: 36 YR
• Patient Weight: 137