MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 10X22MM IMPLANT HEAD; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Item #: unknown stem lot #: unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03145.

Event Description

It was reported a patient underwent a procedure and was revised eight years post implantation due to migration of screw from explor radial head/stem which resulted in loosening of implant.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Cmp-(b)(4).Reported event was confirmed by review of radiographs and examination of complaint sample.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.Visual examination of the returned product identified the locking screw (subcomponent of the stem subform) and the head.Cosmetic inspection did not find any damages to the screw.Dimensional analysis was performed on the screw and identified it was conforming.Wear marks were noted on the head and no damages were found on the threads.Radiographs identified that a right radial head replacement has been performed.Radiocapitellar alignment is maintained.The radial head implant appears displaced with a prominent space between the implant neck and the radius.Bone quality is osteopenic.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 10X22MM IMPLANT HEAD
• 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: 12846706
• MDR Text Key: 283659294
• Report Number: 0001825034-2021-03144
• Device Sequence Number: 1
• Product Code: KWI
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 11-210031
• Device Lot Number: 342980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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: 49 YR
• Patient Sex: Male