MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE ULNAR ASSEMBLY FOR CEMENTED USE ONLY SMALL RIGHT; EXTREMITIES, IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Insufficient Information (4580)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item# 32810502506; lot# 11022221; interchangeable humeral assembly.Report source: foreign: event occurred in (b)(6).The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01019.Remains implanted.
Event or Problem Description
It was reported that the patient had yellowish secretion after elbow arthroplasty surgery.The patient was prophylactically and proactively treated for infection, however infection had never been confirmed nor diagnosed as all cultures taken resulted negative for bacteria/infection, and the surgeon suspects reaction to the cement.Patient underwent an additional procedure to remove graft and wires that may have contributed to the event.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided, however upon review by a health care professional, they were not sent to mmi due to wound healing/infection and sending images would not enhance the investigation for this cause.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: INTERCHANGEABLE ULNAR ASSEMBLY FOR CEMENTED USE ONLY SMALL RIGHT
• Common Device Name: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11712296
• Report Number: 0001822565-2021-01020
• Device Sequence Number: 19941865
• Product Code: JDC
• UDI-Device Identifier: 00889024274129
• UDI-Public: (01)00889024274129(17)231231(10)64122517
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K001989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 32810505302
• Device Lot Number: 64122517
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Other