MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER NEXEL TOTAL ELBOW VIVACIT-E HIGHLY CROSSLINKED POLY ARTICULATION KIT; PROSTHESIS, ELBOW

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094)
Date of Event	05/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source belgium.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.Will be returned but not yet.
Event or Problem Description
It was reported that a patient underwent an initial total elbow arthroplasty that was implanted approximately 7 years ago.Subsequently, the patient had some pain 6 years later and was revised to exchange the polyethylene.During the revision, polyethylene wear was noted and the surgeon took a bit of bone off of the coranoid.Further, synovitis and a little bit of fluid were present within the joint.Due diligence is in progress for this complaint, to date no additional information or product has been received.If further information is received, a follow-up will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Updated: a1, a2, a3, a4, b4, b5, b7, d1, d2, d4 (item, lot, exp date, udi), d6a, g3, g4, h1, h2, h4, h10 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).Reported event was unable to be confirmed due to limited information received from the customer.Radiographs were provided.However, they were not reviewed by a health care professional as the image is undated and due to the presence of staples it appears to be either initial post-op or post-revision, neither of which would enhance the investigation.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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).The reported event has been confirmed for ulnar bearings through product return.As the humeral bearing was not returned for evaluation, wear on the humeral bearing cannot be confirmed.Visual examination of the returned ulnar bearings identified signs of use and wear on the surface that interacts with the ulnar component.The humeral bearing was not returned for evaluation.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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: ZIMMER NEXEL TOTAL ELBOW VIVACIT-E HIGHLY CROSSLINKED POLY ARTICULATION KIT
• 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: 16942084
• Report Number: 0001822565-2023-01332
• Device Sequence Number: 12252874
• Product Code: JDC
• UDI-Device Identifier: 00889024271463
• UDI-Public: (01)00889024271463(17)210228(10)63282606
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 04/09/2024
• 2 Devices were Involved in the Event: 1 2

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: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 00840009500
• Device Lot Number: 63282606
• 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: 05/06/2023
• Supplement Date Received by Manufacturer: 08/02/2023; 09/19/2023; 03/21/2024
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 08/29/2023; 09/27/2023; 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2016
• 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: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 85 KG