MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXTRA SMALL LONG RIGHT 4.5 INCH LENGTH CEMENTED INTERCHANGEABLE ULNAR; PROSTHESIS, ELBOW

Model Number	32-8105-93-02
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient is being considered for a right shoulder revision procedure due fracture of the ulna component.No revision has been reported to date.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).G2: foreign- uk.D10: cat# 32810503506, lot# 64631849.Interchangeable humeral assembly for cemented use only small long flange.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device 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: b4, d2, g3, g6, h1, h2, h3, h6, h10.Proposed code: mechanical (g04)- stem.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.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.
Event or Problem Description
It was reported that the patient is being considered for a right shoulder revision procedure due to the loosening of the ulna component.No revision has been reported to date.No additional patient consequences were reported.

• Brand Name: EXTRA SMALL LONG RIGHT 4.5 INCH LENGTH CEMENTED INTERCHANGEABLE ULNAR
• 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: 17127385
• Report Number: 0001822565-2023-01207
• Device Sequence Number: 7377034
• Product Code: JDC
• UDI-Device Identifier: 00889024274204
• UDI-Public: (01)00889024274204(17)211130(10)63519676
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K001989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 08/03/2023

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: 11/30/2021
• Device Model Number: 32-8105-93-02
• Device Catalogue Number: 32810509302
• Device Lot Number: 63519676
• 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: 02/03/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Unknown