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

Catalog Number	11-210042
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item# 11-210063; lot# 355530.G2: foreign - event occurred in norway.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.
Event or Problem Description
It was reported that a patient underwent a shoulder arthroplasty approximately five (5) years ago.Subsequently, the patient experienced possible loosening of radial stem, radial pain, and extension deficit 30 degrees.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: a1; b4; b5; d2; g1; g3; g6; h1; h2; h10.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 a patient underwent a left shoulder arthroplasty approximately five (5) years ago to repair the fracturing of the patient's native radial head after experiencing a trauma.Subsequently, the patient experienced possible loosening of radial stem, radial pain, and extension deficit 30 degrees.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; g1; g3; g6; h1; h2; h3; h6.H6: proposed annex g code: mechanical (g04) - head.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: immediate post-operative and unknown follow-up duration lateral views of the elbow after radial head replacement.The presumed follow-up image shows proximal radial neck resorption, a well-known phenomenon, particularly related to press-fit radial stems.There is a small focus of heterotopic ossification anterior to the arthroplasty collar.No other findings of loosening are identified.Operative notes were provided and reviewed by a health care professional.Review of the available records identified no relevant findings for the revision procedure.Review of the device history record(s) identified no deviations or anomalies during manufacturing for part 11-210042.For heterotopic ossification: the reported event was determined to be unrelated to the reported products.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: EXPLOR MODULAR RADIAL HEAD
• 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: 22538413
• Report Number: 0001825034-2025-02173
• Device Sequence Number: 20689272
• Product Code: KWI
• UDI-Device Identifier: 00880304438309
• UDI-Public: (01)00880304438309(17)260701(10)702610
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K051385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 12/18/2025

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 Expiration Date: 07/01/2026
• Device Catalogue Number: 11-210042
• Device Lot Number: 702610
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 12/18/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 07/29/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2016
• 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: Other
• Patient Sex: Unknown