MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXEL ULNAR COMPONENT PLASMA SPRAYED RIGHT; ELBOW, ARTHROPLASTY

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 01662, 0001822565 - 2019 - 01666, 0001822565 - 2019 - 01667.Not returned to manufacturer.

Event Description

It has been reported that patient had initial elbow arthroplasty procedure.Subsequently, within one (1) year of initial procedure, patient experienced right elbow pain, swelling, and had an aspiration performed within the doctor's office.The surgeon noted a rare form of staph infection.Further, radiolucency and loosening which were noted in one (1) year x-rays.Patient underwent a revision procedure.All components were removed and replaced with antibiotic cement spacers and an external fixation device.No additional patient consequences were reported.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history records 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.

Event Description

No further event information available at the time of this report.

• Brand Name: NEXEL ULNAR COMPONENT PLASMA SPRAYED RIGHT
• Type of Device: ELBOW, ARTHROPLASTY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8548801
• MDR Text Key: 143031289
• Report Number: 0001822565-2019-01665
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• 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: 00840002407
• Device Lot Number: 63363910
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 00840004415, HUMERAL COMPONENT, 63229436; 00840009000, HUMERAL SCREW KIT, 63807803; 00840009400, ARTICULATION KIT, 63760999; 00840004415, HUMERAL COMPONENT, 63229436; 00840009000, HUMERAL SCREW KIT, 63807803; 00840009400, ARTICULATION KIT, 63760999
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 104