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

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Date 11/16/2019

Event Type  malfunction  

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 underwent a pin and bushing revision to address severe pain.The device was identified loose upon clinical assessment.No further information is available at the time of this reporting.

Event Description

No further information 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.  the following sections were updated: b4; b5; d10; g4; g7; h1; h2; h3; h6 visual examination of the returned product identified ulna bushing is gouged and worn; accurate dimensional analysis not possible.Both humeral bushings are gouged and worn; accurate dimensional analysis not possible.Both the inner pin and outer pin have gouges and scratched.Inner pin prongs are bent but not fractured.Dimensions taken on inner and outer pin are confirming to print specifications.Unable to perform a compatibility check.Medical records were not provided.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: incomplete integration of bone on hardware in the distal humerus, possibly related to loosening, although this cannot be confirmed without comparisons to prior imaging, particularly the immediate postoperative image.Dhr was reviewed and no discrepancies relevant to the reported event were found.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.

Event Description

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

• Brand Name: PIN/BUSHING REPLACEMENT KIT
• Type of Device: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9378070
• MDR Text Key: 168068576
• Report Number: 0001822565-2019-05028
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00889024508590
• UDI-Public: (01)00889024508590
• 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
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 32810502501
• Device Lot Number: 62945969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2020
• 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