MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR MODULAR RADIAL STEM WITH SCREW; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Catalog Number	11-210062
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial elbow implantation approximately one (1) year ago after experiencing an isolated, comminuted fracture of the radial head two (2) days prior.Subsequently, the patient underwent a revision approximately eleven (11) months post-implantation due to loosening of the radial head prosthesis.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item# 11-210032; lot# 311110.E1: full establishment name - (b)(6).G2: foreign - event occurred in poland.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 location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10.H6: proposed component code - mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The reported event is not 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: EXPLOR MODULAR RADIAL STEM WITH SCREW
• Common Device Name: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• 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: 21860662
• Report Number: 0001825034-2025-01126
• Device Sequence Number: 4695884
• Product Code: KWI
• UDI-Device Identifier: 00880304210455
• UDI-Public: (01)00880304210455(17)330826(10)66148576
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Report Date (Section B): 08/11/2025

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: 11-210062
• Device Lot Number: 66148576
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 28 YR
• Patient Sex: Male