MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISC CONDYLE KIT W/ HEXALOBULA; PROSTHESIS, ELBOW

Catalog Number	114700
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure thirteen years post implantation due to articulation failure and a fracture of the screw tip.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat: 114749 lot: 537600 5x75mm rt disc ulna ha/pc.Cat: 114709, lot: 687970 6x100mm rt disc hmrl ha/pc.G2: foreign- italy.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.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 is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of pictures and radiographs.Visual examination of the provided pictures identified the explanted products.However, due to the quality of the photo and the biological debris on the explanted items, further analysis cannot be performed.Review of the available radiographs identified the following: implant fracture is not confirmed.Metallic fragments both radial and ulnar to the distal humeral component.Device is used for treatment.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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
It was reported that the patient underwent a right elbow revision approximately 13 years post-implantation due to articulation failure and screw breakage with a broken screw tip.During the revision, implant removal was described as very difficult because a screw was stuck, with strong fixation of the cementless ulna and humerus components.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: b5; d9; h2; h3; h6; h11.The following sections were corrected: d4.Visual examination of the returned product identified the screw connecting the condyles has fractured.The ulnar bearing is also worn down and in pieces.The ulnar and humeral stems were also returned damaged; however, they were noted to be well-fixed and difficult to remove.Dimensional analysis of the returned product, where measured, was found conforming to specifications.A definitive root cause remains unchanged and cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DISC CONDYLE KIT W/ HEXALOBULA
• 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: 18355137
• Report Number: 0001825034-2023-02977
• Device Sequence Number: 6408213
• Product Code: JDC
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2026

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 Expiration Date: 10/31/2020
• Device Catalogue Number: 114700
• Device Lot Number: 666480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/06/2023
• Supplement Date Received by Manufacturer: 04/02/2024; 03/25/2026
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 04/04/2024; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2010
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male