Optetrak 200-04-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862039736), received between Oct 9, 2024 and Mar 31, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K932776); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, DISCOMFORT, PROSTHESIS WEAR, ASEPTIC LOOSENING AND OSTEOLYSIS. AS A RESULT, APPROXIMATELY SEVEN YEARS AND EIGHT MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. IT WAS NOTED THAT "THE PATIENT HAD SIGNIFICANT POLYETHYLENE WEAR ON THE TIBIAL SURFACE." MOREOVER, SURGEON INDICATED "THERE WAS GROSS OSTEOLYTIC DEBRIS. THE TIBIAL BASEPLATE WAS EASILY EXTRACTED AND FRANKLY LOOSE. THE FEMORAL COMPONENT, ALTHOUGH WELL FIXATED, UPON REMOVAL, THERE WAS A SIGNIFICANT OSTEOLYTIC NON-CONTAINED CAVITARY DEFECT THAT EXTENDED INTO THE POSTERIOR CONDYLE." NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Osteolysis; Pain; Unspecified Tissue Injury

  MAUDE report 24745518 ↗
• InjuryMar 19, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REPORT #1 OF 2 FOR THIS EVENT. IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED ASEPTIC (NON-INFECTED) LOOSENING, PAIN, SWELLING, STIFFNESS AND PROSTHESIS WEAR. AS A RESULT, APPROXIMATELY ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE. IT WAS REPORTED THE TIBIAL INSERT COMPONENT HAD SIGNIFICANT WEAR AND THE TIBIAL TRAY COMPONENT WAS LOOSE. IT WAS REPORTED THE PATIENT PRESENTS TO BE DOING WELL POST THE RIGHT KNEE REVISION. THE PATIENT WAS REVISED TO ANOTHER MANUFACTURER'S CONSTRUCT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 24638997 ↗
• InjuryJun 24, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED A 52 YO MALE PATIENT WHO HAD A RIGHT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 10 YEARS AND 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO PREMATURE POLYETHYLENE WEAR WITH MASSIVE OSTEOLYSIS. ASSOCIATED WITH A PSEUDOTUMORAL LESION IN THE POPLITEAL AREA SECONDARY TO A FOREIGN BODY REACTION CAUSED BY POLYETHYLENE PARTICLES. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION. THIS IS 1 OF 3 REPORTS FOR THIS INCIDENT.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Osteolysis

  MAUDE report 22320208 ↗
• InjuryJan 28, 2025Unstable; Naturally Worn; Migration; Unstable; Naturally Worn; Migration

  IT WAS REPORTED THAT APPROXIMATELY 101 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, METALLOSIS, PAIN, JOINT LAXITY, JOINT INSTABILITY, OSTEOLYSIS ON THE MEDIAL FEMORAL CONDYLE, AND TIBIAL BONE LOSS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE." THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0019-2022. 200-73-11 - CR TIBIAL INSERT SZ 3, 11MM, SLOPE ++ SERIAL: (B)(6). 510K: K932690. UDI: (B)(4). PRODUCT CODE: JWH. X-RAY: NO. OPERATIVE NOTES: YES. CONCOMITANT DEVICES: (B)(6) 13A2101 - CEMEX SYSTEM FAST GENTA 70G. (B)(6) 200-03-32 - ONE PEG PATELLA 32MM. (B)(6) 200-04-33 - CEMENTED FINNED TIB. TRA SZ 3F/3T. (B)(6) 201-78-78 - 4" DRILL BIT, HEX, 2 PK. (B)(6) 232-02-03 - OPTETRAK ASY, CR POROUS FEMORAL, SZ 3, LEFT. (B)(6) ASA0030 - STERILE DISPOSABLE CONTAINERS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Scar Tissue

  MAUDE report 21251849 ↗
• InjuryJan 9, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 103 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS DUE TO SEVERE PROXIMAL TIBIAL BONE LOSS SECONDARY TO OSTEOLYSIS. THE PATIENT EXPERIENCED INCREASING PAIN AND INSTABILITY, AND RECENT INABILITY TO WALK. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. INTRAOPERATIVE FINDINGS INDICATED COPIOUS FIBRINOUS SCAR, TISSUE HEMOSIDERIN-STAINED SYNOVITIS, AND SEGMENTED BONE LOSS FROM THE PROXIMAL TIBIA WAS NOTED FROM THE MEDICAL ASPECT OF THE TIBIAL TUBERCLE GOING AROUND COUNTER-CLOCKWISE TO THE LATERAL ASPECT OF THE TIBIAL TUBERCLE. THE SURGEON PERFORMED A RIGHT TOTAL KNEE REVISION ARTHROPLASTY. THE PATIENT WAS THEN TRANSFERRED TO RECOVERY IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 21119135 ↗
• InjuryJan 7, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 175 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FEMORAL LOOSENING, TIBIAL LOOSENING, SEVERE OSTEOLYSIS AND DESTRUCTION OF HER DISTAL FEMORAL METAPHYSIS AS WELL AS SIGNIFICANT PAIN, INSTABILITY, AND SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 21093791 ↗
• InjuryDec 31, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 146 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, INSTABILITY, JOINT LAXITY, PAIN, SCAR TISSUE, SYNOVITIS, AND FAILURE OF IMPLANT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint Laxity; Pain; Scar Tissue; Synovitis

  MAUDE report 21048288 ↗
• InjuryOct 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA: IT WAS REPORTED THAT APPROXIMATELY 203 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER 0808109 IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0019-2022.

  Patient problems: Insufficient Information

  MAUDE report 20408090 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932776. One submission often covers many models, so check the product and lot details in each record.

• Z-0927-06 · Dec 19, 2005 · Terminated
  Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONL
• Z-1379-05 · Jun 2, 2005 · Terminated
  The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SING