MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 14X22MM IMPLANT HEAD; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER/EXTREMITIES

Catalog Number	11-210033
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Insufficient Information (4580)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial elbow arthroplasty approximately two (2) years and four months ago.The patient underwent an initial revision surgery due to an unknown reason approximately eight (8) months ago.Subsequently, the patient underwent a second revision surgery due to the implant disassociating.Attempt has been made to obtain additional information.No additional information has been received at this time.
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 11-210062, explor 7x26mm impl stem w/scr; lot#: 244340.G2: foreign: belgium.H3: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.H6: component codes: mechanical (g04) - head.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: b4, b5, g3, g6, h2, h6, h11.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial elbow arthroplasty approximately two (2) years and four months ago.The patient underwent an initial revision surgery due to an unknown reason approximately eight (8) months ago.Subsequently, the patient underwent a second revision surgery due to the implant disassociating.The patient was experiencing pain and rom issues.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h11.The reported event was confirmed by review of x-rays.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: postoperative lateral x-ray on showed normal position/alignment of the revised explor radial head modular system.Subsequent lateral x-ray on 6 months later showed disassembly of the modular radial head system.Visual examination of the returned product identified all three items show signs of use and wear and tear.The head returned has scratches on the bottom of the head and there is wear and tear in the groove of the head where the stem would be inserted.There is also wear and tear on the working surface of the head.The head diameter and assembly/groove slot width were measured and conforming.The stem returned has scratches and gouging on the groove of the stem that would be inserted into the head.There also appears to be some debris attached to the bottom side of the stem and the coating as well.The stem diameter and width of the groove assembly feature were measured and conforming.The screw returned has some damage to the threads.The shaft diameter and overall screw length were measured and conforming.All three items were returned dis-assembled.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: EXPLOR 14X22MM IMPLANT HEAD
• Common Device Name: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22729529
• Report Number: 0001825034-2025-02385
• Device Sequence Number: 18247411
• Product Code: KWI
• UDI-Device Identifier: 00880304210394
• UDI-Public: (01)00880304210394(17)330330(10)65978244
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K040611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 01/29/2026

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: 11-210033
• Device Lot Number: 65978244
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 12/17/2025; 01/15/2026
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 01/08/2026; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown