MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PIN/BUSHING REPLACEMENT; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Pain (1994); Discomfort (2330)

Event Date 06/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up/final report will be submitted.Not returned to manufacturer.

Event Description

It was reported the patient was revised for a pin/bushing exchange due to unknown reasons.No further information is available at the time of this reporting.

Event Description

It was reported the patient underwent a pin and bushing revision to address pain and discomfort.No further information is available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No device was returned for examination.Review of device history records was not possible as the necessary product/lot code combination was not provided.Root cause is unknown.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 information is available at the time of this reporting.

Event Description

No further information is available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information.Part/lot and subsequent manufacturing date and expiration date were originally reported incorrectly.The information is unknown.The investigation is in process.Once the investigation has been completed, a follow-up/final report will be submitted.

• Brand Name: UNKNOWN PIN/BUSHING REPLACEMENT
• Type of Device: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9418136
• MDR Text Key: 169292067
• Report Number: 0001822565-2019-05130
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00889024273924
• UDI-Public: 00889024273924
• Combination Product (y/n): N
• PMA/PMN Number: K001989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/30/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32810502501
• Device Lot Number: 62945969
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 12/17/2019; 01/29/2020; 01/29/2020
• Supplement Dates FDA Received: 12/27/2019; 01/30/2020; 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 102