MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PIN/BUSHING REPLACEMENT KIT EXTRA SMALL; PROSTHESIS, ELBOW

Catalog Number	32810502701
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Aseptic loosening (4883)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: brazil.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 a patient presented with loosening of the prosthesis approximately two months post implantation.No further intervention has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported that the patient underwent an initial right total elbow arthroplasty with unknown products on an unknown date.Subsequently, the patient underwent a revision surgery due to pain, instability, and mobility limitations approximately eight (8) months ago with zimmer biomet components at that time.It was later noted on a follow up x-ray approximately six (6) months ago that the bushing pin had loosened.The patient underwent an additional revision surgery approximately four (4) months ago to exchange the pin only.There are not further details available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b3; b4; d2; d6b; g2; g3; g6; h1; h2; h3; h6.The following sections were corrected: a2; b2; b5; b6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: three views of the right elbow labeled intraoperative images dated on (b)(6) 2024 demonstrate an elbow arthroplasty in place with metallic pin or fragment within the proximal radius.The hinge pin is intact.Single view of the right elbow labeled follow-up images dated on (b)(6) 2024 demonstrate single image of an elbow arthroplasty with loosening of the hinge pin as well as a linear metallic fragment within the proximal radius.It has been determined that the bearing kit used is not compatible with the humeral and ulnar components.This was identified to be a contributing factor to the disassociation; however, it cannot be determined if the use of this kit caused the reported event.A definitive root cause cannot be determined.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: PIN/BUSHING REPLACEMENT KIT EXTRA SMALL
• Common Device Name: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21066862
• Report Number: 0001822565-2025-00025
• Device Sequence Number: 20953452
• Product Code: JDC
• UDI-Device Identifier: 00889024639768
• UDI-Public: (01)00889024639768(17)280211(10)65715763
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K181307
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: 32810502701
• Device Lot Number: 65715763
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Unknown