MAUDE Adverse Event Report: ZIMMER INC UNKNOWN ORTHOPAEDIC IMPLANT; ORTHOPAEDIC PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the patient experienced an infection within the first few weeks of surgery.

Manufacturer Narrative

Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Therefore the device history records could not be reviewed and a complaint history search for related complaints could not be conducted.No devices were received; therefore the condition of the components is unknown.Surgical notes were not provided; it is unknown whether the components were implanted as per the surgical technique.A definitive root cause cannot be determined with the information 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.

• Brand Name: UNKNOWN ORTHOPAEDIC IMPLANT
• Type of Device: ORTHOPAEDIC PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• 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: 5554709
• MDR Text Key: 42072834
• Report Number: 1822565-2016-00896
• Device Sequence Number: 1
• Product Code: MOO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• 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: 04/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other