MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100MM; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Model Number	N/A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Event occurred in the (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.
Event or Problem Description
It was reported radiographic assessment identified loosening of the humeral prosthesis.No further treatment is planned at present.The patient is tolerating.No further information has been made available at this time.
Additional Manufacturer Narrative
The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable as this event has been reported under a different medwatch report.This event was reported under medwatch# 0001822565-2022-01243.The initial report was forwarded in error and should be voided.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100MM
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9215371
• Report Number: 0001822565-2019-04500
• Device Sequence Number: 387759
• Product Code: JDC
• UDI-Device Identifier: 00889024271340
• UDI-Public: 00889024271340
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 05/03/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00840004410
• Device Lot Number: 63313336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/13/2019
• Supplement Date Received by Manufacturer: 03/30/2020; 05/02/2022
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 03/31/2020; 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• 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
• 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: 00840002407 ULNAR COMPONENT LOT # 63480682; 00840009000 HUMERAL SCREW KIT LOT # 63610436; 00840009400 ARTICULATION KIT LOT # 63419001
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 52 KG