Optetrak 208-04-43Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862053411), received between Jul 31, 2023 and Jul 31, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

34 other recalls cover devices cleared under the same FDA submission (K023186); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2023Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  AS REPORTED VIA LEGAL DOCUMENTATION THE MALE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2009. APPROXIMATELY 13 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2023; DIAGNOSIS: FAILED RIGHT KNEE ARTHROPLASTY SECONDARY TO TIBIAL LOOSENING AND MASSIVE OSTEOLYSIS. FINDINGS CONSISTENT WITH POLYETHYLENE-INDUCED SYNOVITIS. A SYNOVECTOMY WAS PERFORMED. IT WAS CLEAR THAT THE TIBIA HAD FAILED INTO VARUS WITH SIGNIFICANT MEDIAL BONE LOSS. THERE WAS DELAMINATION OF THE TIBIAL POLYETHYLENE. THERE WAS AN AREA OF MASSIVE OSTEOLYSIS UNDER THE ANTERIOR TROCHLEA THAT HAD ALREADY BEEN APPRECIATED BY THE CT SCAN. THERE WAS ALSO SIGNIFICANT OSTEOLYSIS OF THE MEDIAL FEMORAL CONDYLE. THE PATIENT WAS TRANSFERRED TO THE PACU IN STABLE CONDITION WITHOUT COMPLICATION.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aseptic loosening; Implant Pain; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17423128 ↗

Recalls under the same FDA submission

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

• Z-0130-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX.
• Z-0129-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.
• Z-0131-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, 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-0128-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.
• Z-0137-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX.
• Z-0154-2018 · Sep 19, 2017 · Terminated
  Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.
• Z-0126-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, 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-0148-2018 · Sep 19, 2017 · Terminated
  Optetrak Constrained Condylar Offset Screw, Size DD, Ref 208-04-72, Sterile, RX.
• Z-0156-2018 · Sep 19, 2017 · Terminated
  Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.
• Z-0134-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile, RX.
• Z-0132-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, 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-0142-2018 · Sep 19, 2017 · Terminated
  Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.

…and 19 more.