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

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Ossification (1428); Adhesion(s) (1695); Bone Fracture(s) (1870); Loss of Range of Motion (2032); Scar Tissue (2060)

Event Date 01/21/2020

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 device was re-implanted.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 months post implantation due to loosening of the ulnar prosthesis from a periprosthetic fracture.After debriding extensive scar tissue, the ulnar component was removed, rinsed, and re-cemented into the medullary canal.Autograft bone chips, fibular allograft, bone putty, and cerclage wires were used to stabilize the ulna upon re-implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of medical records received.Medical records were provided and reviewed by a health care professional.Review of the available records identified the biceps tendon considerably thinned and scarred, lesions of the ossifications and adhesions reduce the mobility of the elbow to 0-90-40°.Proximal part of the ulna has grown together well again after bone guild up, pseudarthrosis at the transition from the middle to the proximal area.¿there are now 2 defect sections of bone, one in the area of the pseudarthrosis and the other further distally in the area of the erupted or migrated prosthesis tip.Basic spooling of the entire situs.The endoprosthesis has broken out distally and ventrally radially and is still relatively stuck proximally.Ulnar component removed and rinsed, reimplanted into prepared and cemented medullary canal.Fibular bone chips, allograft, 8 cerclage wires, and additional fiberwires used to stabilize ulna the device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• 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: 11495312
• MDR Text Key: 240338436
• Report Number: 0001825034-2021-00650
• 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: 05/18/2021

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: 05/18/2021
• 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