MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 9X30MM IMPL STEM W/SCR; PROSTHESIS, ELBOW

Catalog Number	11-210064
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Proposed code: mechanical (g04)- stem.D10: cat: 11-210032, lot: 868560, explor 12x22mm implant head.G2: foreign- eu: norway.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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
It was reported that the patient experienced pain in the wrist approximately two months post implantation.The patient underwent ulna shortening osteotomy procedure as a treatment for pain.No further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d5; g1; g3; g6; h1; h2; h3; h6; h10.The reported event is not confirmed.Product has not been evaluated as it has been determined the event is not related to device.Root cause of the reported event is not device related.If any further information is found that 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 is available at the time of this report.

• Brand Name: EXPLOR 9X30MM IMPL STEM W/SCR
• Common Device Name: PROSTHESIS, ELBOW
• 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: 21772977
• Report Number: 0001825034-2025-00993
• Device Sequence Number: 9700766
• Product Code: KWI
• UDI-Device Identifier: 00880304210479
• UDI-Public: (01)00880304210479(17)260806(10)868560
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K051385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/12/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/06/2026
• Device Catalogue Number: 11-210064
• Device Lot Number: 868560
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2016
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown