MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER ; FEMORAL NAIL

Model Number 133240

Device Problems Break (1069); Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Weakness (2145); No Code Available (3191)

Event Date 01/02/2018

Event Type  Injury  

Event Description

Patient had left im rod placed on (b)(6) 2017, began having severe hip pain on (b)(6) 2017 with subsequent fall on (b)(6) 2017.Presented to ortho surgeon on (b)(6) 2018 and x-ray revealed failed hardware.Im rod was broken.Surgical removal and orif of affected side with new hardware.

• Brand Name: ZIMMER
• Type of Device: FEMORAL NAIL
• Manufacturer (Section D): ZIMMER, INC. ; warsaw IN
• MDR Report Key: 7385457
• MDR Text Key: 104032952
• Report Number: 7385457
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/30/2018,03/22/2018

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: 133240
• Device Catalogue Number: 47-2493-383-11
• Device Lot Number: 2883281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2018
• Distributor Facility Aware Date: 01/10/2018
• Event Location: Home
• Date Report to Manufacturer: 03/30/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 38