MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ELBOW COMPONENT REPLACEMENT SET BUSHING AND PINS FOR USE WITH SIZE SMALL ELBOW; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED/EXTREMITIES

Catalog Number	32810600012
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location 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 underwent an initial left elbow surgery on an unknown date.The patient was then revised approximately a month and a half ago due to wearing of the implant.Subsequently, the patient was revised a month ago due to the incorrect implant being implanted into the patient.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2.The following sections were corrected: d1; d4; g4; h4.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: single ap view of the left elbow labeled pre-revision demonstrates a left total elbow arthroplasty with revised hinge pin which appears to be inappropriately sized.Implant disassembly of the hinge pin is noted.The root cause of the reported issue is attributed to use error.It was reported the revision was due to a wrong pin.Mmi confirmed incorrect sizing.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: ELBOW COMPONENT REPLACEMENT SET BUSHING AND PINS FOR USE WITH SIZE SMALL ELBOW
• 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: 20410100
• Report Number: 0001822565-2024-03215
• Device Sequence Number: 7920596
• Product Code: JDC
• UDI-Device Identifier: 00889024274211
• UDI-Public: (01)00889024274211(17)260131(10)63865185
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K973357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2025

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 32810600012
• Device Lot Number: 63865185
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: 10/16/2024; 01/23/2025
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/30/2024; 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female