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

Catalog Number	00840001411
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Insufficient Information (4580); Radiolucent Lines (4848)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial left arthroplasty on and unknown date.Subsequently, the patient is being considered for a revision surgery on an unknown date using a custom vrs ulnar implant due to an unknown reason.Attempt has been made to obtain additional information.No additional information has been received at this time.
Additional Manufacturer Narrative
(b)(4).G2: foreign: united kingdom.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted in the patient.H6: component codes: mechanical (g04)- stem.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d1; d2; d4; g1; g3; g6; h1; h2; h6 if any further information 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 or Problem Description
It was reported by the pmi group that a patient underwent a left elbow arthroplasty on an unknown date approximately two (2) years ago.Subsequently, the patient is being considered for a pmi product on an unknown day due to the patient falling and causing an unspecified failure of the existing ulnar plate.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: a2; b1; b2; b4; b5; b7; d1; d2; d4; d10; g1; g3; g4; g6; h1; h2; h4; h6.D10: item# 00840004415; lot# 64632008.Item# 00840009400; lot# 66432569.Item# 00840009000; lot# 66789277.H6: proposed component code - mechanical (g04) - stem.If any further information 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 or Problem Description
It was reported by the pmi group that a patient underwent a left elbow arthroplasty on an unknown date approximately two (2) years ago.Subsequently, the patient is being considered for a pmi product on an unknown day due to multiple factors including loosening of a non-zb plate (that was later removed on an unknown date), and a fractured nexel ulnar component.It was stated the patient experienced multiple falls; however, it is unknown whether one of the falls caused the fracture of the ulnar component.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left total elbow arthroplasty with chronic loosening of the ulnar stem.Visit 1 images show a fracture through the mid-portion of the metallic ulnar stem with adjacent ulnar diaphysis and cement mantle fracture.Visit 2 images show chronic loosening of the ulnar stem and nondisplaced ulnar diaphysis fracture, but no implant fracture.Review of the device history records identified no deviations or anomalies during manufacturing.It was indicated that the patient experienced multiple falls.However as the timeline of falls is unknown; a definitive root cause cannot be determined.The event was confirmed.If any further information 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: ZIMMER NEXEL TOTAL ELBOW ULNAR COMPONENT
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• 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: 22564264
• Report Number: 0001822565-2025-02602
• Device Sequence Number: 21152961
• Product Code: JDC
• UDI-Device Identifier: 00889024271234
• UDI-Public: (01)00889024271234(17)300630(10)64720566
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00840001411
• Device Lot Number: 64720566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 02/19/2026; 03/04/2026
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 01/07/2026; 02/24/2026; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown