MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ULNA; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Fracture, Arm (2351)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted to relay on initial information and investigation results.Reported event was confirmed by x-ray review.X-ray review states fractures of both forearm bones.Given the appearance of the fragments and lack of significant soft tissue swelling regionally, this is believed to be subacute or chronic in nature.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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.Zimmer biomet will continue to monitor for trends.

Event Description

The patient underwent the first of a two stage revision due to periprosthetic fracture approximately 4 years post implantation; an elbow prosthesis and intramedullary nail, which had been used to treat a previous ulnar fracture, were removed and the patient is awaiting re-implantation with custom components.

• Brand Name: UNKNOWN ULNA
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7283560
• MDR Text Key: 100473850
• Report Number: 0001822565-2018-00995
• Device Sequence Number: 1
• Product Code: PAE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention