MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR® RADIAL STEM; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Failure to Osseointegrate (1863); Migration (4003)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 07/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported that patient had an initial radial head replacement.Subsequently, approximately ten (10) months post-implantation, the patient underwent a revision procedure due to pain, subluxation of the radial head and radiographic stem loosening.During revision surgery, when the radial stem was removed, there was no bone integration on the stem.Doctor decided not to implant anything yet and observe.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays.As per x-ray review, there is lucency along the stem, consistent with loosening.Dhr was reviewed and no discrepancies were found.Root cause was unable to 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.

• Brand Name: EXPLOR® RADIAL STEM
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7843516
• MDR Text Key: 119102973
• Report Number: 0001825034-2018-08652
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: PK051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• 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: 11-210063
• Device Lot Number: 561880
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: EXPLOR® RADIAL HEAD; EXPLOR® RADIAL HEAD
• Patient Outcome(s): Hospitalization; Required Intervention