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

Model Number	114991
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Metal Related Pathology (4530)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical products: disc xs hum 3.5x84mm lt flange cat: cp561029 lot: 0338770.Source foreign: (b)(6).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 report will be submitted.Product not returned.
Event or Problem Description
It was reported a patient underwent an initial elbow arthroplasty.Subsequently, due to fracture of distal humerus bone, revision surgery was performed.During the surgery, condyle screws came out easily, therefore, the surgeon assumed that metallosis may have occurred between the implant and the screws.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned products confirmed that there is no discoloration to the male or female threads as they do show signs of wear.Dimensional analysis was performed on the threads.The hexalobular condyle locking screws of the print shows major thread both were in tolerance.The humeral flanged elbow thru diameter of two thread holes were measured.The pin passed all the way thru the two threaded holes.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined for why the humerus bone fractured.As for the the screws being easily removed during the revision surgery, no device problem was identified that would have caused or contributed to the reported event.A summary of the investigation has been sent to the complainant.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
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g7, h1, h2, h10 per previous investigation, this product did not cause or contribute to the event.This report will be investigated under medwatch: 0001825034-2022-01563.This report will be considered not reportable.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: DISC XS CONDYLE KIT W ALIGN
• Common Device Name: ELBOW, PROSTHESIS
• 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: 14932852
• Report Number: 0001825034-2022-01562
• Device Sequence Number: 12491323
• Product Code: JDC
• UDI-Device Identifier: 00880304469365
• UDI-Public: (01)00880304469365(17)260301(10)229300
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• 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): 11/03/2022

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: 03/01/2026
• Device Model Number: 114991
• Device Catalogue Number: 114991
• Device Lot Number: 229300
• 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: 06/06/2022
• Supplement Date Received by Manufacturer: 08/03/2022; 10/21/2022; 11/02/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 08/25/2022; 10/26/2022; 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2016
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female