MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXEL ULNA STEM; ELBOW PROSTHESIS/EXTREMITIES

Catalog Number UNKNOWN

Device Problem Unintended Movement (3026)

Patient Problem Neuropathy (1983)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Morrey me, songy c, triplet jj, cheema an, o¿driscoll sw, sanchez, sotelo j, morrey bf, unexpected high early failure rate of the nexel total elbow arthroplasty, jses international (2022), doi: https://doi.Org/10.1016/j.Jseint.2022.04.001.Component code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.Medical records were not provided.A definitive root cause cannot 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

It was reported in a journal article that a patient underwent transposition of the ulnar nerve for postop neuropathy.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN NEXEL ULNA STEM
• Type of Device: ELBOW PROSTHESIS/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14566709
• MDR Text Key: 293192033
• Report Number: 0001822565-2022-01652
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention