MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BIGLIANI FLATOW HUMERAL HEAD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Tissue Damage (2104); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ext-bf shoulder anatomic/primary unk-glenoid component lot#unk item#unk, ext-bf shoulder anatomic/ primary unk-stem lot# unk item# unk.The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The compatibility check and complaint history search were not performed.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-03369, 0001822565-2018-00806.

Event Description

It is reported that the patient underwent shoulder arthroplasty revision due to an adverse reaction that the patient was experiencing, including pain and bone deterioration, to the implants.The surgeon opted to treat the case with a temporary cement spacer.The surgeon plans to further treat the patient with custom implants on a later date.No additional patient consequences are reported.

• Brand Name: UNKNOWN BIGLIANI FLATOW HUMERAL HEAD
• Type of Device: PROSTHESIS, SHOULDER
• 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: 7262378
• MDR Text Key: 99768954
• Report Number: 0001822565-2018-00805
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2018
• 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