Knee Instruments 11.00005Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07630030877384), received between Feb 14, 2019 and Jul 18, 2019 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (14 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2019Material Fragmentation; Material Fragmentation

  AFTER THE IMPLANTATION THE SURGEON NOTICED THAT 1 OUT OF THE 4 SPIKES OF THE BASE INSERT FOR PATELLA CLAMP WAS MISSING. THE MISSING PIN WAS FOUND ON THE PATIENT PATELLA AND TENDON. THE SURGEON WAS ABLE TO RETRIEVE THE PIN FROM THE PATIENT BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8802791 ↗
• MalfunctionJul 17, 2019Material Fragmentation; Material Fragmentation

  AFTER THE IMPLANTATION THE SURGEON NOTICED THAT 1 OUT OF 4 SPIKE OF THE BASE INSERT FOR PATELLA CLAMP WAS MISSING. MISSING PIN FOUND AROUND PATIENT PATELLA AND TENDON. THE SURGEON WAS ABLE TO RETRIEVE THE PIN FROM THE PATIENT BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8798336 ↗
• MalfunctionJun 21, 2019Material Fragmentation; Material Fragmentation

  DURING THE PRIMARY SURGERY, AFTER THE CEMENTATION, THE SURGEON REMOVED THE PATELLA CLAMP, AND DISCOVERED 3 OUT OF 4 SPIKES OF THE BASE INSERT FOR THE PATELLA CLAMP WERE BROKEN. THE SURGEON WAS ABLE TO RETRIEVE THE PINS FROM THE PATIENT BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8721211 ↗
• MalfunctionJun 19, 2019Material Fragmentation; Material Fragmentation

  AFTER THE IMPLANTATION, THE SURGEON NOTICED THAT 1 OUT OF 4 SPIKES OF THE BASE INSERT FOR PATELLA CLAMP WAS MISSING. MISSING PIN FOUND AROUND PATIENT PATELLA AND TENDON. THE SURGEON WAS ABLE TO RETRIEVE THE PIN FROM THE PATIENT BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8711135 ↗
• MalfunctionJun 18, 2019Material Fragmentation; Material Fragmentation

  AFTER THE PATELLA IMPLANTATION THE SURGEON NOTICED THAT 4 OUT OF 4 SPIKES OF THE BASE INSERT FOR PATELLA CLAMP WERE BROKEN. PINS PARTS FOUND AROUND PATIENT PATELLA AND TENDON. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PARTS FROM THE PATIENT BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY, 5 MINUTES OF DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8707534 ↗
• MalfunctionJun 5, 2019Material Fragmentation; Material Fragmentation

  AFTER THE CEMENTATION, THE SURGEON REMOVED THE PATELLA CLAMP AND DISCOVERED THAT 3 OUT OF 4 SPIKES OF THE BASE INSERT FOR THE PATELLA CLAMP WERE BROKEN. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN SPIKES FROM THE PATIENT BODY. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 5 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8670157 ↗
• MalfunctionMay 2, 2019Material Fragmentation; Material Fragmentation

  AFTER THE CEMENTATION, THE SURGEON REMOVED THE PATELLA CLAMP AND DISCOVERED 1 OUT OF 4 SPIKES OF THE BASE INSERT FOR THE PATELLA CLAMP WAS BROKEN (THE BROKEN PIECE HAS BEEN RETRIEVED FROM THE PATIENT), THE REMAINING 3 SPIKES SEEM TO BE BEND. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN SPIKE FROM THE PATIENT BODY. THE SURGEON CUTS PATELLA WITHOUT ANY GUIDE AND POKES PEG HOLES THROUGH A BLUE GUIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8573530 ↗
• MalfunctionApr 18, 2019Material Fragmentation; Material Fragmentation

  AFTER THE CEMENTATION, THE SURGEON REMOVED THE PATELLA CLAMP AND DISCOVERED THAT THE 4 SPIKES OF THE BASE INSERT FOR THE PATELLA CLAMP WERE BROKEN. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN SPIKES FROM THE PATIENT BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8527544 ↗
• MalfunctionApr 11, 2019Material Fragmentation; Material Fragmentation

  AFTER THE CEMENTATION, THE SURGEON REMOVED THE PATELLA CLAMP AND DISCOVERED 3 OUT OF 4 SPIKES OF THE BASE INSERT FOR THE PATELLA CLAMP WERE BROKEN. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN SPIKES FROM THE PATIENT BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8503596 ↗
• MalfunctionApr 10, 2019Material Fragmentation; Material Fragmentation

  WHEN THE SURGEON OPENED THE PATELLA INSTRUMENT SET DISCOVERED THAT THE BLUE LEVER OF THE PATELLA CLAMP WAS BROKEN, IN SPITE OF THIS, HE USED THE INSTRUMENT. AFTER THE CEMENTATION, THE SURGEON REMOVED THE PATELLA CLAMP, AND DISCOVERED 1 OUT OF 4 SPIKE OF THE BASE INSERT FOR THE PATELLA CLAMP BROKE. THE SURGEON WAS ABLE TO RETRIEVE THE PINS FROM THE PATIENT BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8498764 ↗
• MalfunctionApr 3, 2019Material Fragmentation; Material Fragmentation

  AFTER THE CEMENTATION, THE SURGEON REMOVED THE PATELLA CLAMP AND DISCOVERED 1 OUT OF 4 SPIKES OF THE BASE INSERT FOR THE PATELLA CLAMP BROKEN. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIN FROM THE BODY OF THE PATIENT. WE DO NOT REPORT THIS EVENT TO PMDA.

  Patient problems: Failure of Implant

  MAUDE report 8478385 ↗
• MalfunctionMar 28, 2019Material Fragmentation; Material Fragmentation

  WHEN THE SURGEON OPENED THE GMK-EFFICIENCY TRAY, IT WAS NOTICED THAT THE LOCK LEVER OF THE PATELLA CLAMP WAS BROKEN, THE SURGEON HAS CONTINUED TO GRIP THE PATELLA CLAMP UNTIL THE CEMENTATION. AFTER THE CEMENTATION, THE SURGEON REMOVED THE PATELLA CLAMP, AND DISCOVERED THAT 1 OF THE 4 SPIKES OF THE BASE INSERT FOR THE PATELLA CLAMP WAS BROKEN. THE SURGEON WAS ABLE TO RETRIEVE THE PIN FROM THE PATIENT BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8460365 ↗
• MalfunctionMar 28, 2019Material Fragmentation; Material Fragmentation

  AFTER THE CEMENTATION, THE SURGEON REMOVED THE PATELLA CLAMP AND DISCOVERED THAT 2 OUT OF 4 SPIKES OF THE BASE INSERT FOR THE PATELLA CLAMP WERE BROKEN. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PINS FROM THE PATIENT BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8460363 ↗
• MalfunctionMar 22, 2019Material Fragmentation; Material Fragmentation

  AFTER THE CEMENTATION, THE SURGEON REMOVED THE PATELLA CLAMP AND DISCOVERED THAT 3 SPIKES OF THE BASE INSERT FOR PATELLA CLAMP WERE COMPLETELY BROKEN. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PINS FROM THE PATIENT BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8443623 ↗
• MalfunctionMar 6, 2019Fracture; Fracture

  WHEN THE SURGEON TRIED TO CLAMP, THE LOCK LEVER OF THE PATELLA CLAMP BROKE. THE SURGEON CONTINUED TO GRIP THE PATELLA CLAMP UNTIL THE CEMENTATION, AFTER THE CEMENTATION, THE SURGEON REMOVED THE PATELLA CLAMP AND DISCOVERED 3 OUT OF 4 SPIKES OF THE BASE INSERT WERE BROKEN. THE SURGEON WAS ABLE TO RETRIEVE THE PINS FROM THE PATIENT BODY.

  Patient problems: No Information

  MAUDE report 8394718 ↗
• MalfunctionFeb 21, 2019Break

  AFTER THE PATELLA IMPLANTATION, THE SURGEON NOTICED THAT 2 OUT OF 4 SPIKES OF THE BASE INSERT FOR PATELLA CLAMP WERE BROKEN. MISSING PINS WERE FOUND AROUND PATIENT PATELLA AND TENDON. THE SURGEON WAS ABLE TO RETRIEVE THE PINS FROM THE PATIENT'S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8358045 ↗
• MalfunctionFeb 21, 2019Component Missing

  AFTER THE IMPLANTATION, THE SURGEON NOTICED THAT 1 OUT OF 4 SPIKES OF THE BASE INSERT FOR PATELLA CLAMP WAS MISSING. THE MISSING SPIKE WAS FOUND AROUND PATIENT PATELLA AND TENDON. THE SURGEON WAS ABLE TO RETRIEVE THE PIN FROM THE PATIENT BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8358041 ↗
• MalfunctionFeb 14, 2019Break

  AFTER THE IMPLANTATION THE SURGEON NOTICED THAT 1 OUT OF 4 SPIKES OF THE BASE INSERT FOR PATELLA CLAMP WAS BROKEN. MISSING PIN WAS FOUND AROUND THE PATIENT'S PATELLA AND TENDON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8338978 ↗