MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN HEAD; PROSTHESIS, HEAD

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 07/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Concomitant medical products: unk, unknown liner, unk; unk, unknown cup, unk; unk, unknown stem, unk.(b)(4).Report source, literature - mcgrory, b.Et al (2017).High early major complication rate after revision for mechanically assisted crevice corrosion in metal-on-polyethylene total hip arthroplasty.The journal of arthroplasty, 1-7.Doi: 10.1016/j.Arth.2017.07.004.Reported event was unable to be confirmed due to limited information 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 was unable to be determined.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 - 05805; 0001822565 - 2017 - 05806; 0001822565 - 2017 - 05807.- (b)(4).

Event Description

It has been reported in a journal article that 31 patients were revised for unknown reasons.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN HEAD
• Type of Device: PROSTHESIS, HEAD
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6795111
• MDR Text Key: 82753396
• Report Number: 0001822565-2017-05804
• Device Sequence Number: 1
• Product Code: LZY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 07/19/2017
• 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