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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER TRIAL FEMORAL HEAD 32MM NEUTRAL
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ZIMMER TRIAL FEMORAL HEAD 32MM NEUTRAL Back to Search Results
Catalog Number 789503202
Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/22/2015
Event Type  Injury  
Event Description
On (b)(6) 2015, surgeon was doing a right total hip arthroplasty and was trialing the femoral head with zimmer trial heads.As the surgeon was removing the trial component, the component became dislodged.C-arm and portable x-rays were obtained to locate the trial head; trial head was not visible.A second trial head component was also became dislodged.The total hip arthroplasty was completed and the surgeon closed.On (b)(6) 2015, ct scan obtained and revealed two rounded radiopaque foreign bodies located within the right lower aspect of the pelvis.One trial head located along the right lateral margin of the urinary bladder and the other is abutting the medial aspect of the right iliac bone just below the si joint.On (b)(6) 2015, pt returned to surgery and underwent a retroperitoneal exploration of the right pelvis and removal of the two foreign bodies.
 
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Brand Name
TRIAL FEMORAL HEAD 32MM NEUTRAL
Type of Device
TRIAL FEMORAL HEAD 32MM NEUTRAL
Manufacturer (Section D)
ZIMMER
warsaw IN 46580
MDR Report Key5344165
MDR Text Key35162221
Report NumberMW5058876
Device Sequence Number1
Product Code KWY
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number789503202
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/30/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age83 YR
Patient Weight31
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