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

Catalog Number	00840004415
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial elbow arthroplasty on an unknown date.Subsequently, the patient is planned to undergo a revision on a date not yet scheduled due to potential delamination of the nexel humeral implant noted by the surgeon in post-op x-rays.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in australia.H6: proposed component code - mechanical (g04) - stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b3; b4; b5; d1; d2; d4; d6; d10; g1; g3; g4; g6; h1; h2; h4.D10: item# 00840001411; lot# 62875414.Item# 00840009000; lot# 65143434.Item# 00840009400; lot# 64737347.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 that the patient underwent an elbow revision approximately three (3) years and four (4) months post-implantation due to delamination of the nexel humeral implant noted by the surgeon in post-op x-rays.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d9; d10; g1; g3; g6; h1; h2; h3; h6.D10: item# 00840001411; lot# 62875414.Item# 00840009000; lot# 65143434.Item# 00840009400; lot# 64737347.Item# 00840019402; lot# 64935878.Item# 00840019402; lot# 64935878.Visual examination of the returned product identified that the humeral component shows signs of wear and tear with some wear marks near the plasma coating on the proximal end of the stem.There is also some staining/discoloration on the proximal end of the stem.The plasma coating on the shaft of the stem has one particle that is attached, the rest of the plasma coating in that area is missing.An unknown foreign substance was embedded in the returned poly bearings visually consistent with the porous coating.Radiographs were reviewed by a healthcare professional.The single image contains an amplified view of an xr, limiting the assessment.The issue was confirmed through product return and delamination may not be accurately captured on plain film; therefore the image was not submitted to radiology for further assessment.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ZIMMER NEXEL TOTAL ELBOW HUMERAL 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: 22472149
• Report Number: 0001822565-2025-02452
• Device Sequence Number: 8113050
• Product Code: JDC
• UDI-Device Identifier: 00889024271357
• UDI-Public: (01)00889024271357(17)300908(10)64813820
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 10/23/2025

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: 00840004415
• Device Lot Number: 64813820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 10/22/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/08/2025; 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown