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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

Information was received via journal article.Please reference literature at the following location: http://www.Tandfonline.Com/doi/full/10.3109/17453674.2016.1162898.This report will be amended when our investigation is complete.

Event Description

It was reported that 1 periprosthetic fracture hip arthroplasty revision became re-fractured requiring another surgery.

Manufacturer Narrative

Device was not returned and no photos were received; therefore, condition of the device is unknown.The lot number of the product is unknown; therefore, the device history records and complaint history could not be reviewed.Compatibility could not be confirmed as part number is unknown.The reported device is used for treatment.A definitive root cause could not be determined with the information provided.

Manufacturer Narrative

Event date submitted in error.

• Brand Name: UNKNOWN ZIMMER CPT FEMORAL 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: 6002718
• MDR Text Key: 56590289
• Report Number: 0001822565-2016-03563
• Device Sequence Number: 1
• Product Code: KWZ
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• 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?: Yes
• Date Manufacturer Received: 12/15/2016
• 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): Hospitalization; Required Intervention