MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN DISCOVERY ULNAR COMPONENT; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Migration (4003)

Patient Problem No Information (3190)

Event Date 10/01/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown humeral component.Report source - foreign: (b)(6).Reported event was unable to be confirmed as part number and lot number of the device involved in the incident is unknown.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.R.Large, a.Tambe, t.Cresswell, m.Espag, d.I.Clark, from the royal derby hospital, derbyshire, united kingdom.The journal of bone and joint surgery, www.Jbjs.Org, volume 96-b, number 10, october 10, 2014; 96-b:1359¿65.Doi:10.1302/0301-620x.96b10.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-09808 - [(b)(4)].

Event Description

It was reported in a journal article that five (5) events of radiolucencies were identified.These five progressed, but without complete loosening and were reported to be monitored.There has been no further information provided and the patients' outcome is unknown.

• Brand Name: UNKNOWN DISCOVERY ULNAR COMPONENT
• Type of Device: PROSTHESIS, ELBOW
• 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: 7976294
• MDR Text Key: 124065107
• Report Number: 0001825034-2018-09809
• Device Sequence Number: 1
• Product Code: KWI
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2014
• 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): Other