MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISC CONDYLE KIT W/ HEXALOBULA; EXTREMITIES, IMPLANT

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 114816, lot# 265200, disc ulna 3x115mm lt w/brng c.Item# 114918, lot# 310670, disc hum 6x150mm lt flanged c.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02659, 0001825034-2019-02661.Product not returned.

Event Description

It was reported that the patient underwent left total elbow arthroplasty.Subsequently, the patient underwent a revision procedure due to damaged humeral condyle kit and bearings, and severe catastrophic wear of the ulnar component.No additional patient consequences were reported.

Manufacturer Narrative

Upon receipt of additional information, it was determined that zimmerbiomet does not hold reporting responsibility for the reported device.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of additional information, it was determined that zimmerbiomet does not hold reporting responsibility for the reported device.The initial report was forwarded in error and should be voided.

• Brand Name: DISC CONDYLE KIT W/ HEXALOBULA
• Type of Device: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8770961
• MDR Text Key: 150376172
• Report Number: 0001825034-2019-02660
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K051975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• 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: 114700
• Device Lot Number: 385190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention