Optetrak 200-04-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885862039705), received between Aug 30, 2019 and Jun 9, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REPORT #2 OF 3 FOR THIS EVENT. AS REPORTED BY LEGAL DOCUMENTATION, A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY TEN (10) YEARS LATER, THE PATIENT PRESENTED TO SURGEON COMPLAINING OF PAIN UNRELATED TO INJURY/WORK INJURY. PATIENT REPORTS 8 OUT OF 10 ON PAIN SCALE IN LEFT AND RIGHT KNEES. ONGOING INTERMITTENT ACHING. GRADUALLY WORSENING. AGGRAVATED BY: BENDING, STRETCHING, STRAIGHTENING, EXERCISE, KNEELING, SQUATTING, STANDING, WALKING, STAIRS. PATIENT REPORTED FALLING ON BOTH KNEES WHILE WALKING THE DOG. RADIOGRAPHS, PER THE SURGEON APPEARS TO DEMONSTRATE LUCENCY ABOUT THE TIBIAL PLATEAU COMPONENT OF THE PROSTHESIS AND FEMORAL COMPONENT OF THE PROSTHESIS ON THE LEFT THAT MAY REPRESENT LOOSENING. MEDICAL RECORDS AND CLINICAL HISTORY WERE PROVIDED. IT IS UNKNOWN IF THE PATIENT UNDERWENT REVISION OF THE LEFT KNEE OR IF A LEFT KNEE REVISION IS PLANNED OR SCHEDULED. THE PATIENT WAS REFERRED TO AN ORTHOPAEDIC SURGEON FOR CONSULTATION OF POSSIBLE REVISION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Fall; Pain

  MAUDE report 25449804 ↗
• InjuryApr 8, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY 7.5 YEARS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT COMPLAINED OF KNEE SWELLING AND PAIN AND WAS DIAGNOSED WITH WEAR OF THE TIBIAL INSERT. THE PATIENT WAS REVISED AND DAMAGE AND WEAR WERE OBSERVED ON THE RETRIEVED TIBIAL INSERT, AS WELL AS THE TIBIAL TRAY. THE SURGEON DECIDED THAT ONLY THE INSERT AND TIBIAL TRAY NEEDED TO BE REPLACED WITH A TRULIANT CRC SIZE 2 15 MM INSERT AND TIBIAL TRAY 2F/1T. A STEM EXTENTION 14MM×40MM, 1/2 TIBIAL AUGMENT SIZE 1T-5MM (X2), 1/2 TIBIAL AUGMENT RM/LL SIZE 1T-10MM AND 1/2 TIBIAL AUGMENT RL/LM SIZE 1T-10MM WERE ALSO USED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24815175 ↗
• InjuryMar 30, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY 9 YEARS AND 11 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT COMPLAINED OF KNEE SWELLING AND PAIN. THE SURGEON DIAGNOSED WEAR OF THE TIBIAL INSERT AND THE PATIENT WAS REVISED. BREAKAGE AND WEAR WERE OBSERVED IN THE RETRIEVED TIBIAL INSERT. THE SURGEON DECIDED THERE WAS NO PROBLEM WITH THE LOCKING MECHANISM OF THE TIBIAL TRAY, AND ONLY THE INSERT WAS REPLACED WITH A NEW TRULIANT CR SIZE 2, 13MM NEUTRAL INSERT. POLYETHYLENE PARTICLES WERE REMOVED BY THE SURGEON APPROPRIATELY. THE SURGEON FOUND METALLOSIS, BUT THE TIBIAL TRAY WAS LEFT. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 24727091 ↗
• InjuryJul 2, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SEVEN YEARS AFTER THE PRIMARY TOTAL KNEE ARTHROPLASTY USING A CR SLOPE ++ TIBIAL INSERT, THE PATIENT COMPLAINED OF KNEE SWELLING AND PAIN. THE SURGEON DIAGNOSED WEAR OF THE TIBIAL INSERT, AND REVISION SURGERY WAS PERFORMED TO REPLACE IT. BREAKAGE AND WEAR WERE OBSERVED IN THE RETRIEVED TIBIAL INSERT, AND METALLOSIS WAS ALSO NOTED. THE SURGEON DETERMINED THAT THERE WAS NO ISSUE WITH THE LOCKING MECHANISM OF THE TIBIAL TRAY. AFTER REMOVING ALL PROLIFERATIVE TISSUE, ONLY THE INSERT WAS REPLACED WITH A NEW ONE.

  Patient problems: Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 22381868 ↗
• InjuryJan 31, 2025Unstable; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 98 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, BALANCE PROBLEMS, DISCOMFORT, IMPLANT PAIN, JOINT LAXITY, AND OSTEOLYSIS. INITIAL SURGERY AND 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: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Metal Related Pathology; Osteolysis

  MAUDE report 21282620 ↗
• InjuryJan 28, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. AFTER THE LEFT TOTAL KNEE REPLACEMENT SURGERY, THE PATIENT BEGAN TO SUFFER FROM SYMPTOMS INCLUDING BUT NOT LIMITED TO PROSTHETIC WEAR, INSTABILITY AND LOOSENING, PAIN AND LACK OF MOBILITY. AS A RESULT OF THESE SYMPTOMS, PATIENT UNDERWENT LEFT KNEE REVISION SURGERY APPROXIMATELY 2 YEARS 4 MONTHS AFTER THEIR INITIAL REPLACEMENT. THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANTS AND THE BONES, WHICH LEFT TO ASEPTIC (NON-INFECTED) LOOSENING AND INSTABILITY. HOWEVER, THIS CANNOT BE CONFIRMED AS THE EXPLANTED DEVICES WERE NOT RETURNED FOR EVALUATION, AND RADIOGRAPHS/PHOTOGRAPHS WERE NOT PROVIDED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. 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; Balance Problems; Failure of Implant; Joint Laxity; Pain; Synovitis

  MAUDE report 21255830 ↗
• InjuryJan 13, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 117 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND LOOSENING OF THE TIBIAL COMPONENT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POSTOPERATIVE DIAGNOSIS NOTED LOOSE LEFT KNEE TIBIAL COMPONENT. INTRAOPERATIVELY TWO WOUND CULTURES WERE SENT OFF WITH NO INFECTION APPRECIATED AND CULTURE RESULTS WERE UNREMARKABLE. IT WAS NOTED THAT THE SURGEON ELECTED DO THE TIBIAL REVISION AND NOT THE WHOLE KNEE. IT WAS NOTED THAT THE TIBIAL COMPONENT WAS SIGNIFICANTLY LOOSE. PATIENT WAS REVISED TO EXACTECH DEVICES. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137833 ↗
• InjuryNov 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A TOTAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2011 AND THEN APPROXIMATELY 12 YEARS, 11 MONTHS LATER ON (B)(6) 2024 THE PATIENT HAD A SURGICAL REVISION. REVISION OPERATIVE REPORT (B)(6) 2024-POSTOPERATIVE DIAGNOSIS: ASEPTIC LOOSENING OF RIGHT TOTAL KNEE. PATIENT REVISED TO COMPETITOR'S DEVICES. PATIENT WITH RADIOGRAPHIC EVIDENCE OF ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS WITH AREAS OF OSTEOLYSIS IN FEMUR AND TIBIA. NEGATIVE FOR INFECTION. THERE IS EVIDENCE OF CATASTROPHIC POLYETHYLENE WEAR WITH VISUAL DETERIORATION OF THE POLYETHYLENE WITH MULTIPLE POLYETHYLENE FRAGMENTS THROUGHOUT THE KNEE. PATELLA POLYETHYLENE COMPONENT WAS UNDERMINED WITH AREAS OF OSTEOLYSIS. THE PATIENT HAS EXPERIENCED IMPLANT PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS AWAKENED AND BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION PROVIDED.

  Patient problems: Implant Pain; Osteolysis

  MAUDE report 20791270 ↗
• InjuryNov 6, 2024Unstable; 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 9 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, INSTABILITY, ASEPTIC LOOSENING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 20619610 ↗
• InjurySep 24, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 10 MONTHS POST THE PREVIOUS REVISION SURGERY, THE PATIENT HAD KNEE PAIN AND THE SURGEON DECIDED TO REVISE AGAIN BECAUSE THE FEMORAL AND TIBIAL COMPONENTS HAD BEEN FOUND TO BE LOOSE. METALLOSIS WAS FOUND AND ALL PROLIFERATIVE TISSUE REMOVED, THEN ALL COMPONENTS WERE REPLACED TO COMPETITOR DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Implant Pain; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 20297679 ↗
• InjuryAug 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2018 APPROXIMATELY 6 YEARS AND 2 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); Insufficient Information; Synovitis

  MAUDE report 19991565 ↗
• InjuryMay 17, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY TWELVE YEARS POST INITIAL LEFT TKA, THE FEMALE PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH PAIN IN HER LEFT KNEE. THE X-RAYS SHOWED POSSIBLE WEAR OR VARUS STRESS. THE TIBIA BONE LOOKS SUSPECT ON X-RAY. THE PATIENT WAS SCHEDULED FOR A REVISION TKA POSSIBLE POLY SWAP. UPON ENTERING THE KNEE JOINT, REMOVING THE POLY, AND TESTING/CHECKING THE FEMORAL AND TIBIAL COMPONENTS, IT WAS FOUND THAT THE TIBIAL COMPONENT WAS LOOSE ON THE BONE. THE SURGEON WAS ABLE TO LIFT IT UP OFF THE BONE EASILY WITH AN OSTEOTOME. THE SURGEON REMOVED ALL OF THE EXACETCH IMPLANTS AND COMPLETED A TOTAL KNEE REVISION USING COMPETITOR'S REVISION KNEE SYSTEM. THERE WAS NO BREAKAGE OF DEVICES. THERE WAS A 30-45 MINUTE SURGICAL DELAY/PROLONGATION DUE TO THE LOOSE IMPLANTS CAUSING A LONGER PROCEDURE THAN ANTICIPATED OF A POLY SWAP BUT THERE WAS NO ADVERSE EVENT AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE REVISION PROCEDURE. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO IMPLANTS WERE DISPOSED OF BY THE FACILITY.

  Patient problems: Failure of Implant

  MAUDE report 14420944 ↗
• InjuryAug 30, 2019Loose or Intermittent Connection; Naturally Worn; Appropriate Device Problem Term/Code Not Available; Naturally Worn

  INDEX SURGERY: (B)(6) 2012. PENDING REVISION DUE TO LOOSENING OF THE FINNED TIBIAL TRAY. THE SURGERY HAS BEEN PUT ON HOLD UNTIL THE PATIENT LOSES AT LEAST 30 POUNDS, PER SURGEON'S ADVICE.

  Patient problems: Failure of Implant; Pain; Weight Changes

  MAUDE report 8949471 ↗

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