NA 209-57-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862056696), received between Sep 16, 2019 and Jul 20, 2020 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

39 other recalls cover devices cleared under the same FDA submission (K023186, K150890, K935726, K954208); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2020Break; Break

  DURING A REVISION FROM A PRIMARY TO A CC. IT HAS HAPPENED WHILE LOCKING THE INSERT TO THE BASE PLATE, RESULTING IN MAJOR DIFFICULTIES TO RETRIEVE THE BROKEN TIP LEFT IN THE SCREW HEAD. ALL PIECES WERE RETRIEVED, WITH LESS THAN 5 MIN DELAY TO SURGERY. THE TIP WAS DISCARDED AND WILL NOT RETURN, THE DRIVER WILL BE RETURNING. NO PATIENT INFO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10298805 ↗
• MalfunctionJul 20, 2020Break; Break

  DURING A REVISION FROM A PRIMARY TO A CC. IT HAS HAPPENED WHILE LOCKING THE INSERT TO THE BASE PLATE, RESULTING IN MAJOR DIFFICULTIES TO RETRIEVE THE BROKEN TIP LEFT IN THE SCREW HEAD. ALL PIECES WERE RETRIEVED, WITH LESS THAN 5 MIN DELAY TO SURGERY. THE TIP WAS DISCARDED AND WILL NOT RETURN, THE DRIVER WILL BE RETURNING. NO PATIENT INFO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10298722 ↗
• MalfunctionJul 20, 2020Break; Break

  DURING A REVISION FROM A PRIMARY TO A CC, WHILE LOCKING THE INSERT TO THE BASE PLATE, THE BALL TIP DRIVER BROKE, RESULTING IN MAJOR DIFFICULTIES TO RETRIEVE THE BROKEN TIP LEFT IN THE SCREW HEAD. ALL PIECES WERE RETRIEVED, WITH LESS THAN 5 MIN DELAY TO SURGERY. THE TIP WAS DISCARDED AND WILL NOT RETURN, THE DRIVER WILL BE RETURNING. NO PATIENT INFO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10298663 ↗
• MalfunctionJul 20, 2020Break; Break

  DURING A REVISION FROM A PRIMARY TO A CC, WHILE LOCKING THE INSERT TO THE BASE PLATE, THE BALL TIP DRIVER BROKE, RESULTING IN MAJOR DIFFICULTIES TO RETRIEVE THE BROKEN TIP LEFT IN THE SCREW HEAD. ALL PIECES WERE RETRIEVED, WITH LESS THAN 5 MIN DELAY TO SURGERY. THE TIP WAS DISCARDED AND WILL NOT RETURN, THE DRIVER WILL BE RETURNING. NO PATIENT INFO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10297878 ↗
• MalfunctionJul 20, 2020Break; Break

  DURING A REVISION FROM A PRIMARY TO A CC, WHILE LOCKING THE INSERT TO THE BASE PLATE, THE BALL TIP DRIVER BROKE, RESULTING IN MAJOR DIFFICULTIES TO RETRIEVE THE BROKEN TIP LEFT IN THE SCREW HEAD. ALL PIECES WERE RETRIEVED, WITH LESS THAN 5 MIN DELAY TO SURGERY. THE TIP WAS DISCARDED AND WILL NOT RETURN, THE DRIVER WILL BE RETURNING. NO PATIENT INFO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10297769 ↗
• MalfunctionJul 20, 2020Break; Break

  DURING A REVISION FROM A PRIMARY TO A CC, WHILE LOCKING THE INSERT TO THE BASE PLATE, THE BALL TIP DRIVER BROKE, RESULTING IN MAJOR DIFFICULTIES TO RETRIEVE THE BROKEN TIP LEFT IN THE SCREW HEAD. ALL PIECES WERE RETRIEVED, WITH LESS THAN 5 MIN DELAY TO SURGERY. THE TIP WAS DISCARDED AND WILL NOT RETURN, THE DRIVER WILL BE RETURNING. NO PATIENT INFO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10297225 ↗
• MalfunctionJul 20, 2020Break; Break

  DURING A REVISION FROM A PRIMARY TO A CC. IT HAS HAPPENED WHILE LOCKING THE INSERT TO THE BASE PLATE, RESULTING IN MAJOR DIFFICULTIES TO RETRIEVE THE BROKEN TIP LEFT IN THE SCREW HEAD. ALL PIECES WERE RETRIEVED, WITH LESS THAN 5 MIN DELAY TO SURGERY. THE TIP WAS DISCARDED AND WILL NOT RETURN, THE DRIVER WILL BE RETURNING. NO PATIENT INFO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10296497 ↗
• MalfunctionDec 12, 2019Break; Break

  AS REPORTED, THE SURGEON WAS TORQUEING THE EXTENSION SCREW DOWN IN THE TIBIAL TRAY TO LOCK DOWN THE STEM. THE TIP OF THE BALL DRIVER BROKE INSIDE THE HEAD OF THE EXTENSION SCREW. THE SURGEON WAS NOT ABLE TO REMOVE THE SCREW HEAD, SO IT WAS LEFT AND THE TIBIAL TRAY WAS CEMENTED IN. THE POLY WAS ALSO PLACED IN OVER TOP LOCKING INTO THE MUSHROOM. THE INCIDENT DID NOT CREATE ANY PROBLEMS DURING OR AFTER THE CASE. THE PATIENT WAS ALERT AND STABLE WHEN LEAVING THE ROOM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9458072 ↗
• MalfunctionSep 16, 2019Break

  AS REPORTED, THE INSTRUMENT BROKE DURING SURGERY. THERE IS NO CLUE IF THE SCREW HAS BEEN TIGHT AT ITS MAX. TIP SNAPPED WHILE TIGHTENING SCREW ON BASE PLATE. THE REP WAS PRESENT. THE BROKEN PART WAS IRRETRIEVABLE FROM SCREW HEAD AND WAS LEFT. THE SNAPPED TIP IS COVERED BY INSERT AND SHOULD NOT BE ABLE TO LOOSEN. THERE WAS NO DELAY TO THE SURGERY. THERE WAS NO DELAY TO THE SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9069959 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023186, K150890, K935726, K954208. One submission often covers many models, so check the product and lot details in each record.

• Z-0582-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-
• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
• Z-1364-2020 · Jan 27, 2020 · Open, Classified
  Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, s
• Z-3209-2018 · May 8, 2018 · Open, Classified
  Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total k
• Z-0129-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.
• Z-0127-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.
• Z-0135-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.
• Z-0158-2018 · Sep 19, 2017 · Terminated
  Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.
• Z-0159-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.
• Z-0133-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23, Sterile, RX.
• Z-0140-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.
• Z-0142-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.
• Z-0138-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.
• Z-0156-2018 · Sep 19, 2017 · Terminated
  Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.
• Z-0145-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.

…and 24 more.