MAUDE Adverse Event Report: ZIMMER BIOMET, INC. C/M ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY EXTRA SMALL; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED/EXTREMITIES

Catalog Number	32810502704
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Osteopenia/ Osteoporosis (2651)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: united kingdom customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial elbow arthroplasty on and unknown date.Subsequently, the patient underwent a revision surgery due to the implant fracturing and bone loss.Multiple attempts have been made to receive additional information.No additional information has been received at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.H6: component codes: mechanical (g04) - stem.X-rays were provided and stem can be seen fractured in x-ray.No product was returned or additional pictures provided; further visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: two views of the elbow labeled pre-revision demonstrate a elbow arthroplasty with fractured humeral component.Significant lucency surrounding the distal humeral component could indicate loosening.Punctate hyperdensity within the joint space could indicate metallosis.Lucency of the proximal radius is noted.Two additional images provided labeled additional pre-revision again demonstrate an elbow arthroplasty with fractured humeral component.Significant lucency surrounding the distal humeral component could indicate loosening also with lucency surrounding the ulnar component.Extensive hyperdense foci within the joint space suggests metallosis.Lucency of the proximal radius is noted.Suggestion of fractured cement along the distal humerus and proximal ulna.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.D10: medical products: item#: (b)(4), extra small right 3 inch length cemented interchangeable ulnar; lot#: 63033895.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial elbow arthroplasty with a non-zimmer biomet product approximately twenty-one (21) years ago.The patient was then revised approximately twelve (12) years later using a coonrad-morrey system for an unknown reason.The patient underwent a second and third revision to revise the link pin and busing approximately four (4) years later.Approximately one (1) year and seven (7) months ago the patient reported pain and a pop.X-rays were performed and a the implant had fractured.Subsequently, the patient was revised approximately five (5) months ago to revise the fractured implant.The patient denies any trauma that would have caused the implant to fracture.

• Brand Name: C/M ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY EXTRA SMALL
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED/EXTREMITIES
• 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: 20624144
• Report Number: 0001822565-2024-03497
• Device Sequence Number: 12980185
• Product Code: JDC
• UDI-Device Identifier: 00889024274006
• UDI-Public: (01)00889024274006(17)200630(10)63019691
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K001989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 04/22/2025

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: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 32810502704
• Device Lot Number: 63019691
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 03/04/2025; 04/16/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 03/26/2025; 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2015
• 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; Hospitalization
• Patient Sex: Unknown