MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE ULNAR ASSEMBLY FOR CEMENTED USE ONLY REGULAR LEFT; EXTREMITIES, IMPLANT ASSEMBLY

Model Number N/A

Device Problems Degraded (1153); Material Erosion (1214); Detachment of Device or Device Component (2907); Naturally Worn (2988)

Patient Problems Patient Problem/Medical Problem (2688); No Information (3190)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign - europe: (b)(6).Item # 32810502606, lot # 60694336, interchangeable humeral assembly.  customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event.Product not returned.

Event Description

It was reported that the patient was implanted with prosthesis on (b)(6) 2009 for complex fracture.Subsequently, following a trauma attack, the patient was revised due to metallosis, polyethylene wear and known decoupling on (b)(6) 2019.No additional patient consequences were reported.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmerbiomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02217.

Event Description

It was reported that the patient underwent initial procedure for complex fracture.Subsequently, following a trauma attack, the patient was revised due to metallosis, polyethylene wear and known decoupling.No additional patient consequences were reported.

• Brand Name: INTERCHANGEABLE ULNAR ASSEMBLY FOR CEMENTED USE ONLY REGULAR LEFT
• Type of Device: EXTREMITIES, IMPLANT ASSEMBLY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8645914
• MDR Text Key: 146235205
• Report Number: 0001822565-2019-02218
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K120906
• 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: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 32810506301
• Device Lot Number: 60785804
• 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): Hospitalization; Other; Required Intervention