MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER FEMORAL COMPONENT; HIP PROSTHESIS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature located at: https://www.Ncbi.Nlm.Nih.Gov/pmc/articles/pmc2947662/.This report will be amended when our investigation is complete.

Event Description

It is reported that an unknown number of patients developed an infection after hip arthroplasty.

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 devices are 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: UNKNOWN ZIMMER FEMORAL COMPONENT
• 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: 6101542
• MDR Text Key: 59842388
• Report Number: 0001822565-2016-04218
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• 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): Other