MAUDE Adverse Event Report: ZIMMER FEMORAL HEAD; TRIAL FEMORAL HEAD

Model Number 32-(10.5)

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/29/2014

Event Type  Injury  

Event Description

A (b)(6) female with left hip osteoarthritis left total hip arthroplasty (b)(6) 2014.When surgeon was using femoral trial head, the head escaped into the pelvis.Attempts to retrieve it were unsuccessful.The equipment remains in the pelvis.Upon continuation of the case patient.Experienced a pelvic fracture which was stabilized during surgery.

• Brand Name: FEMORAL HEAD
• Type of Device: TRIAL FEMORAL HEAD
• Manufacturer (Section D): ZIMMER; warsaw 46581
• MDR Report Key: 4387137
• MDR Text Key: 5436784
• Report Number: MW5039949
• Device Sequence Number: 1
• Product Code: KWY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 32-(10.5)
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZIMMER SIZE 56 TRABECULAR METAL MODULAR SHELL; FOUR 6.5 MM CANCELLOUS SCREWS; 36 PLUS 10.5 COBALT CHROME HEAD; SIZE 7.6 ML TAPER EXTENDED OFFSET STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 73