MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXEL ULNA LT SZ 4 X 171MM; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Year of birth: (b)(6).Concomitant medical devices: nexel humeral component.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Patient underwent initial left total elbow arthroplasty.Subsequently, the patient underwent an additional procedure approximately 6 month post implantation.The patient then sustained a fall and was revised approximately one year later due to implant and periprosthetic fracture.The patient has been indicated for revision when a custom ulnar component is available.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was confirmed by review of photographs and medical records received.Visual examination of the provided pictures identified the explanted product.The stem is fractured and bone cement still appears attached.No other conclusions can be made regarding the implant.Review of the available medical records identified the failure of ulna or fracture of ulna.Removal and bony rehabilitation.Humerus is left in place.Extremity not functional until reimplantation.New special ulna is required.The device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined.A fall/high stress was noted, however, this could not be confirmed as the reason for fracture/loosening.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

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

• Brand Name: NEXEL ULNA LT SZ 4 X 171MM
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11495309
• MDR Text Key: 240118913
• Report Number: 0001825034-2021-00649
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00887868360190
• UDI-Public: (01)00887868360190(17)290625(10)060320
• Combination Product (y/n): N
• PMA/PMN Number: NI
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• 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: CP0002111
• Device Lot Number: 060320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention