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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient is alleging harm caused by the device, however the nature of the harm is unknown at this time.

Manufacturer Narrative

Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.No devices were received; therefore the condition of the components is unknown.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.The complaint was not confirmed, therefore a root cause could not 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.

Event Description

It is reported that the patient is alleging harm caused by the device, however the nature of the harm is unknown at this time.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN ORTHOPEDIC IMPLANT
• Type of Device: ORTHOPEDIC PROSTHESIS
• 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 46582-0708 ; 5745273773
• MDR Report Key: 5857129
• MDR Text Key: 51488128
• Report Number: 0001822565-2016-02740
• Device Sequence Number: 1
• Product Code: MOO
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• 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
• Date Manufacturer Received: 04/06/2017
• 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): Other