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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH FITMORE® PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

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ZIMMER GMBH FITMORE® PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Model Number 01.00551.303
Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/06/2020
Event Type  malfunction  
Event Description
From staff: physical therapist was evaluating this patient same day of surgery for right total hip replacement. While ambulating in hallway with front wheeled walker and returning to bed, suddenly heard a loud "clunk" from the operative side. Patient then stating the operative leg felt much different than before with weight bearing. When returning to the bed, patient stating it felt as if the foot was going through the floor. From op report: patient who underwent a primary right total hip arthroplasty. This was performed under spinal anesthesia without complication. The patient did well in the recovery room and transferred to the floor. Patient was walking with physical therapy without difficulty when there was an audible crack and the right leg shortened. Patient was placed back in bed. Patient did not have significant pain. The x-ray revealed a periprosthetic fracture with displacement of a medial calcar fragment and significant subsidence of the stem. The hip remained located. I suspect that there is a small calcar crack that was not visible at the time of the primary stem placement. Because of the significant amount of subsidence, i recommended that we proceed back to the operating thereafter for revision of the femoral stem and fixation of the fracture fragment same day as original surgery.
 
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Brand NameFITMORE®
Type of DevicePROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Manufacturer (Section D)
ZIMMER GMBH
1800 west center street
warsaw IN 46580
MDR Report Key9732273
MDR Text Key180172532
Report Number9732273
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number01.00551.303
Device Catalogue Number01.00551.303
Device Lot Number2989040
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/11/2020
Event Location Hospital
Date Report to Manufacturer02/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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