MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE ULNAR ASSEMBLY; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Reaction (2414)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed in association with this reporting: 0001822565-2019-04841.Event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated by manufacturer? not returned to manufacturer.

Event Description

It was reported the patient was revised to address significant metallosis, and distal implant wear of humeral component secondary and attributed to bushing pin fracture.No further information is available at the time of this reporting.

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.No product was returned provided; visual and dimensional evaluations could not be performed.However, pictures of the explanted product was provided.It was identified the bushing was fractured.Black debris was visible on the components likely consistent with metallosis.Bio debris was affixed to the stem.The bushing pin fracture cannot be identified from the picture provided.The reported products were reviewed for compatibility with no issues noted.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic lucencies in the distal humerus, which is nonspecific and can represent loosening, but also can be seen in the setting of metallosis.There is angulation of the distal tip of the pin, which is nonspecific and cannot be fully evaluated based upon the provided radiograph image dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9353148
• MDR Text Key: 167321166
• Report Number: 0001822565-2019-04839
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K053189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 32810504302
• Device Lot Number: 61275534
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 32810504302, ULNAR ASSEMBLY , LOT 61275534; 32810504302, ULNAR ASSEMBLY , LOT 61275534
• Patient Outcome(s): Hospitalization; Required Intervention