MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PIN/BUSHING REPLACEMENT KIT EXTRA SMALL; PROSTHESIS, ELBOW

Catalog Number	32810502701
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign- australia.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.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 was revised four years post initial implantation due to revision due to implant fracture.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d4, d10, e1, g3, g6, h1, h2, h4, h11.The following sections were corrected: b5, d1, d2a, d2b, d6a.D10: cat: 32810502704, lot: 64163243 interchangeable humeral assembly for cemented use only extra small 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.
Event or Problem Description
It was reported that the patient had an elbow revision approximately twenty seven (27) months post-initial implantation due to implant breakage.No additional patient consequences were reported.
Event or Problem Description
No further event information is 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, d2, g3, g6, h1, h2, h3, h6, h11.Corrected: h4.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device is used for treatment.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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: PIN/BUSHING REPLACEMENT KIT EXTRA SMALL
• 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: 20454175
• Report Number: 0001822565-2024-03277
• Device Sequence Number: 7204234
• Product Code: JDC
• UDI-Device Identifier: 00889024639768
• UDI-Public: (01)00889024639768(17)280803(10)64596821
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K001989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 02/20/2025

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 Catalogue Number: 32810502701
• Device Lot Number: 64596821
• 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: 10/06/2024
• Supplement Date Received by Manufacturer: 10/09/2024; 02/17/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/07/2024; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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 H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female