MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 12X20MM IMPLANT HEAD; Prosthesis, Elbow, Hemi-, Radial, Polymer

Catalog Number	11-210023
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Joint Contracture (4528); Aseptic loosening (4883)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item #: 11-210063, explor 8x28mm impl stem w/scr, lot # 811940.G2: foreign - event occurred in norway.H6: proposed component code - mechanical (g04) - head.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that after 21 days post implantation patient presented with contracture associated with loss of rotation, flexion, and extension (0°, 100°, 20°).X-rays showed evidence of ectopic bone formation.Intraoperatively, signs of joint ¿stuffing¿ and a head size considered too large were observed.An open arthrolysis was performed, including removal of scar tissue and ectopic bone formation.Scarring against the trochlea from the prosthesis head was also identified.The prosthetic head was removed and replaced with a smaller head measuring 20 mm with a 10 mm length.Post-operative radiation therapy was planned.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported that a patient underwent an initial left elbow arthroplasty.Subsequently the patient was revised approximately 4 months and 16 days post implantation due to loosening, ectopic bone formation, arthrolysis, and pain.During the revision noted scar tissue, implant ¿catching¿ and wear.The head was exchanged for a smaller size without complications.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: b3, b4, b5, d6b, g3, g6, h2, h6, h11 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.

• Brand Name: EXPLOR 12X20MM IMPLANT 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: 24716380
• Report Number: 0001825034-2026-00749
• Device Sequence Number: 6109661
• Product Code: KWI
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2026

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: 11-210023
• Device Lot Number: 424780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 05/21/2026; 09/03/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/16/2026; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2017
• 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: Disability; Required Intervention
• Patient Sex: Male
• Patient Weight: 165 LB