MAUDE Adverse Event Report: BIOMET ORTHOPEDICS EXPLOR 8X28MM IMPL STEM W/SCR; PROSTHESIS, ELBOW

Catalog Number 11-210063

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).No devices or photos of the devices were received; therefore, the condition of the components is unknown.Additionally, visual and dimensional evaluations could not be performed.Per surgical technique, these implants are compatible with one another.Review of the complaint history did not identify any trends; no corrective actions, preventive actions, or field actions resulted after investigation of this event.A definitive root cause of the event could not be determined with the available information.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

Patient identified in a journal article had radiographic evidence of loosening at 6 months post-implantation and reported wrist and elbow pain 40 months post-implantation.Attempts to obtain more information have been made, but none is available.Patient outcome is unknown.

• Brand Name: EXPLOR 8X28MM IMPL STEM W/SCR
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6511771
• MDR Text Key: 73380444
• Report Number: 0001825034-2017-02646
• 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: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 11-210063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• 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): Other
• Patient Age: 58 YR