MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 10X24 MM IMPLANT HEAD; PROSTHESIS, ELBOW, HEMI, RADIAL, POLYMER/EXTREMITIES

Catalog Number 11-210041

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Osseointegration Problem (3003); Insufficient Information (3190)

Patient Problems Joint Dislocation (2374); Osteopenia/ Osteoporosis (2651); Insufficient Information (4580)

Event Date 12/21/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: medical products: item#: 11-210063, explor 8x28mm impl stem w/scr; lot#: 680450 g2: foreign: australia h3: 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.

Event Description

It was reported that a patient underwent an elbow arthroplasty approximately two (2) years ago.Subsequently, the patient was underwent a revision surgery approximately three (3) weeks ago due to an unknown reason.Multiple attempts have been made to obtain additional information, but no response has been received at this time.

Event Description

It was reported that the patient underwent an elbow arthroplasty approximately two (2) years ago.Subsequently, the patient underwent a revision surgery due to the disassociation of the implants and migration of the implant into the joint space which caused considerable damage and bone loss to the articular surface of the distal humerous.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00302.

• Brand Name: EXPLOR 10X24 MM IMPLANT HEAD
• Type of Device: PROSTHESIS, ELBOW, HEMI, RADIAL, POLYMER/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18491040
• MDR Text Key: 332607636
• Report Number: 0001825034-2024-00093
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11-210041
• Device Lot Number: 420100
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2020
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male