MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 9X30MM IMPL STEM W/SCR; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Migration (4003)

Patient Problems Bacterial Infection (1735); Failure of Implant (1924); Loss of Range of Motion (2032)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: explor implant locking screw cat# 11-210099 lot#ni.Explor 14x24 mm implant head cat# 11-210043 lot#ni.Report source: (b)(6).(b)(4).No products were returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records; lot identification was not provided.Medical records were not provided.Legal records were provided and reviewed by a health care professional.Review of the available records identified the following: primary surgery: initial right radial head replacement with lateral ligament reconstruction performed.1 week follow up: no complications on the x-ray.10 week follow up: no issues noted.30 month followup : concerns with elbow, aspiration performed, negative for growth.X-rays indicate proximal migration of the radial head with displacement of the locking screw, concern for septic arthritis.Subsequently, the patient underwent stage 1 revision with placement of antibiotic beads due to infection.Post-revision x-rays demonstrated destructive changes with asymmetry in the humeroulnar joint with volar shift of the distal humerus, but the patient healed well with antibiotic treatment.2 month post revision: x-ray showed destructive changes in the humeroulnar joint with volar shift of the distal humerus, healing well.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00368, 0001825034 - 2022 - 01231.

Event Description

It was reported that a patient underwent a revision procedure approximately 30 months post implantation due to infection and migration of the radial head and locking screw.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: EXPLOR 9X30MM IMPL STEM W/SCR
• 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: 14430002
• MDR Text Key: 291947061
• Report Number: 0001825034-2022-01230
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• 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: 11-210064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female