MAUDE Adverse Event Report: ZIMMER, INC. UKNOWN ZIMMER TAPER STEM; HIP PROSTHESIS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It has been reported that following a total hip arthroplasty, the patient is being scheduled for a revision.The nature of harm and reason for revision is unknown.

Manufacturer Narrative

No device or photo was provided therefore the condition of the component is unknown.Device history records cannot be reviewed since the part and lot numbers are unknown.The reported device is used for the treatment.Complaint history search cannot be reviewed since the part and lot numbers are unknown.Compatibility cannot be checked due to insufficient information.Medical records were not provided.Relevant medical history and adherence to rehabilitation protocol are unknown.A definite root cause cannot be determined with the information provided.

• Brand Name: UKNOWN ZIMMER TAPER STEM
• Type of Device: HIP 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: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6069152
• MDR Text Key: 58842358
• Report Number: 0001822565-2016-04002
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• 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: 03/24/2017
• 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