MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISCOVERY ELBOW SYSTEM; PROSTHESIS, ELBOW, CONSTRAINED

Catalog Number	114833
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); Paresthesia (4421); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent the implantation of a zb total elbow arthroplasty approximately eight (8) years ago.Patient previously had fallen off of a ladder and received a competitor's radial head replacement; however, the patient later required ulnar neurolysis and anteposition, removal of the competitor radial head prosthesis, removal of radio-ulnar synostosis, and removal of heterotopic calcifications due to implant subluxation and radial nerve damage.It was reported that the patient was doing well for years following their implantation of the zb elbow.Subsequently, approximately seven (7) years post-implantation of the zb elbow, the patient was walking and experienced a sudden intense pain in the elbow without associated trauma.X-rays showed implant fracture of the ulnar component and dislocation.Revision surgery has been recommended but not yet scheduled, and patient is continuing to experience pain, swelling, paresthesia and limited motion in the joint and using a brace until the revision occurs.Due diligence is complete as multiple attempts were made; however, no further information is available.As no additional information or product is available, we are unable to provide further information.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item# 114909; lot# 308930.Item# 114700; lot# 688630.G2: foreign - event occurred in italy.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10.H6: proposed component code - mechanical (g04) - stem no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: in the absence of trauma (while walking, therefore during the physiological commuting of the upper limbs), he felt a strange noise in his elbow, which was followed by intense pain in the elbow with absolute functional impotence.Later x-ray on 6 february 2024 showed rupture of the prosthesis.Patient no longer able to drive, continues having pain and mobility limitation, constantly uses a brace immobilizing the joint.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is confirmed by provided medical records.If any further information which would change or alter any conclusions or information, a supplemental report 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.

• Brand Name: DISCOVERY ELBOW SYSTEM
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED
• 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: 21459637
• Report Number: 0001825034-2025-00472
• Device Sequence Number: 7642233
• Product Code: JDC
• UDI-Device Identifier: 00880304215528
• UDI-Public: (01)00880304215528(17)210729(10)125290
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 05/16/2025

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: 07/29/2021
• Device Catalogue Number: 114833
• Device Lot Number: 125290
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 110 KG