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

Model Number N/A

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Discomfort (2330)

Event Date 08/13/2019

Event Type  Injury  

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 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.

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 Description

No further event information available at the time of this report.

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 Description

No further event information available at the time of this report.

• Brand Name: HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100MM
• Type of Device: 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
• MDR Text Key: 163123673
• Report Number: 0001822565-2019-04500
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00889024271340
• UDI-Public: 00889024271340
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 00840002407 ULNAR COMPONENT LOT # 63480682; 00840009000 HUMERAL SCREW KIT LOT # 63610436; 00840009400 ARTICULATION KIT LOT # 63419001
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 52 KG