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

Model Number	01.00551.303
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Event or Problem 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.

• Brand Name: FITMORE®
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): ZIMMER GMBH; 1800 west center street; warsaw IN 46580
• MDR Report Key: 9732273
• Report Number: 9732273
• Device Sequence Number: 352965
• Product Code: KWY
• UDI-Device Identifier: 00889024482876
• UDI-Public: (01)00889024482876
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2020
• Report Date (Section F): 02/11/2020

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
• Operator of Device: No Information
• Device Model Number: 01.00551.303
• Device Catalogue Number: 01.00551.303
• Device Lot Number: 2989040
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 100
• Date Report Sent to FDA: 02/11/2020