MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISC HUM 6X100MM RT FLANGED C; PROSTHESIS, ELBOW

Model Number	114909
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign- (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Device has been discarded.
Event or Problem Description
It was reported that the patient underwent a revision procedure approximately five years post initial implantation due to the loosening of the humeral component.No additional patient consequences were reported.

• Brand Name: DISC HUM 6X100MM RT FLANGED C
• Common Device Name: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11309590
• Report Number: 0001825034-2021-00434
• Device Sequence Number: 19647422
• Product Code: JDC
• UDI-Device Identifier: 00880304215795
• UDI-Public: (01)00880304215795
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K013042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

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 Model Number: 114909
• Device Catalogue Number: 114909
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR