MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXEL ULNAR COMPONENT; PROSTHESIS, ELBOW

Model Number N/A

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

Patient Problem Hematoma (1884)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00840004415, humeral component plasma sprayed size 4 150 mm length, 63229436; 00840009000, humeral screw kit 2 humeral screws, 63807803; 00840009400, articulation kit size 4 1 axle pin, 1 humeral bearing a, 2 ulnar bearings b sterile product, 63760999.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 - 2018 - 04728, 0001822565 - 2018 - 04729.Patient not revised.

Event Description

It has been reported that patient had initial elbow arthroplasty procedure.Subsequently, within one (1) month hematoma was noted.Reportedly, patient got dressing wet, and the wound was macerated with superficial dehiscence.Patient underwent an aspiration and was placed on antibiotics.Post aspiration, no hematoma was present or palpable.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.However it has been noted in the initial operative notes that large pannus formation (arthritic deformity) and synovitis noted during initial surgery.It is reported that the wound healing was slow, however it is stated that the wound was wet.Dhr was reviewed and no discrepancies relevant to the reported event were found.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.

• Brand Name: NEXEL ULNAR COMPONENT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7830572
• MDR Text Key: 118709001
• Report Number: 0001822565-2018-04726
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: PK123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 104