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

Model Number N/A

Device Problem Loss of Osseointegration (2408)

Patient Problem No Information (3190)

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please see associated reports: 0001825034 - 2018 - 04072, 0001825034 - 2018 - 04073, 0001825034 - 2018 - 04074, 0001825034 - 2018 - 04076.Concomitant medical products: unknown part/lot; humeral condyle, distal humeral body, modular stem, unknown srs ic segment.Reported event was confirmed due to patient x-rays received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause could not be determined with information available.Patient x-rays were received and reviewed.Lucency, bone fragments identified and suggestion of osteolysis can be identified as contributing factors for the continual issues of pain and adl difficulty.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.This report is being submitted late as it has been identified in remediation.Not returned to manufacturer.

Event Description

The patient was revised to address humeral loosening.No further information is available at this time.

• Brand Name: UNKNOWN DISCOVERY 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: 7608964
• MDR Text Key: 111301247
• Report Number: 0001825034-2018-04075
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 06/18/2018
• 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
• Patient Age: 69 YR
• Patient Weight: 76