MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER STEM; KWZ

Model Number N/A

Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the surgeon believes the stem is loose and the polyethylene needs to be replaced.

Manufacturer Narrative

This report is being written to relay additional information.

Event Description

It is reported the surgeon believes the stem is loose and the polyethylene needs to be replaced.Additional information received identified the case was cancelled and the patient was not seen again regarding the issue.

Manufacturer Narrative

No product was returned; visual and dimensional evaluations could not be performed.Insufficient information provided, unable to perform a device history record review.The device was used for treatment.Review of the complaint history for unknown anatomic stem identified no additional complaints.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definitive root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN ZIMMER STEM
• Type of Device: KWZ
• 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: 5678365
• MDR Text Key: 45871441
• Report Number: 0001822565-2016-01752
• Device Sequence Number: 1
• Product Code: KWZ
• 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: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2016

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: 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
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/08/2017; 02/23/2017
• 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