MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN EXPLOR POROUS STEM; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Pain (1994)

Event Date 06/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Date of event - journal was published in 2017.Concomitant medical products: unknown, unknown radial head, unknown, unknown, unknown screw, unknown.Report source, foreign ¿ events occurred in (b)(6).Report source, literature - laflamme, m.Et al (2017).Retrospective cohort study on radial head replacements comparing results between smooth and porous stem designs.Journal of shoulder and elbow surgery, 26(8), 1316-1324.Doi: 10.1016/j.Jse.2017.04.008.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Complaint history review was unable to be performed, as the part number and lot number are unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

It has been reported in a journal article that a patient was revised nine months after an initial surgery due to a painful ankylosis/heterotopic ossification excision.The radial head implant was left intact.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN EXPLOR POROUS STEM
• 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: 6908381
• MDR Text Key: 87987295
• Report Number: 0001825034-2017-07580
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2017
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention