MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE HUMERAL ASSEMBLY FOR CEMENTED USE ONLY SMALL; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED/EXTREMITIES

Model Number	32-8105-25-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/13/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the location of the product is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient was undergoing an initial right total elbow arthroplasty with ulnar nerve transposition.Subsequently, a small, minimally displaced fracture of the patient's medial condyle occurred during the procedure as the humerus was driven in fully.The fracture was pinned and there was no further intra-operative complications reported.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.H6: component codes: mechanical (g04) - stem.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional and a timeline was created.Review of the available records identified the following: patient underwent rt.Elbow arthroplasty on (b)(6) 2011 by (b)(6).Full rom achieved with trial components.A small, minimally displaced fracture of the medial condyle occurred as the humerus was driven in fully, this was pinned with a 2.0 wire.Full rom was also achieved with final components.Plan: patient to remain hospitalized overnight for pain control, follow-up visit with imaging in 10 days.No further intra-op complications noted.A definitive root cause cannot 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.

• Brand Name: INTERCHANGEABLE HUMERAL ASSEMBLY FOR CEMENTED USE ONLY SMALL
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED/EXTREMITIES
• 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: 15300263
• Report Number: 0001822565-2022-02454
• Device Sequence Number: 2467654
• Product Code: JDC
• UDI-Device Identifier: 00889024508590
• UDI-Public: (01)00889024508590(17)160331(10)61635055
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K001989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: 32-8105-25-04
• Device Catalogue Number: 32810502504
• Device Lot Number: 61635055
• 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: 08/01/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 60 KG